FDA considers DES safe as ‘morning-after’ pill, 1973

2.5 mg of DES twice a day for 5 days…

1973 Abstract

Food and Drug Administration approval of labeling for diethylstilbestrol (DES) as a postcoital contraceptive is reported.

DES is considered safe only as an emergency contraceptive measure.

The recommended dose is 2.5 mg twice a day for 5 days.

Treatment should be initiated 24-72 hours after coitus. It is important that the full regimen be completed, even if nausea, which is common with oral DES, is present.

There is yet no evidence that DES poses a significant carcinogenic risk to the mother or the fetus. However, if treatment fails, abortion should be seriously considered because of possible teratogenic effects or carcinoma in female offspring.

Sources

  • FDA considers DES safe as ‘morning-after’ pill, JAMA Network PMID: 12257949, 1973 Jun.
  • Featured image TS Radio.
DES DIETHYLSTILBESTROL RESOURCES

Diethylstilbestrol in the Treatment of Rape Victims

image of des-treatment-of-rape-victims

DES used as a postcoital contraceptive ; for abortion purpose

1976 Study Abstract

Despite growing controversy surrounding its use as a “morning after pill,” diethylstilbestrol (DES) is prescribed liberally for rape victims. Guidelines for its use in these patients is lacking.

Of 150 consecutive rape victims treated at a university medical center, 63 (42 percent) received prescriptions for DES. Of the 55 (87 percent) on whom follow-up was obtained, in 40 (73 percent) there were substantial side effects—nausea or vomiting, or both. At least six (11 percent) did not complete therapy because of these side effects.

The authors offer guidelines for use of DES for rape victims and a plan for patient education and follow-up.

Full Text

There has been growing interest in the medical community in improving the health care of rape victims. A chief medical concern during emergency treatment of these patients is prevention of pregnancy. This is usually accomplished in susceptible patients by the prescribing of high doses of diethylstilbestrol (DES), a synthetic estrogen commonly used as a “morning after pill.”

However, recent concern about the use of this drug has been voiced from many quarters-the health profession, lay groups, and government. This concern springs from the results of recently published research implicating DES with subsequent vaginal tumors in female offspring of mothers who took the medication during pregnancy.

The Food and Drug Administration has consequently called for more stringent criteria for use of DES, including the recommendation that should a patient taking DES subsequently discover herself to be pregnant, pregnancy termination be strongly considered.

Historically, rape victims served as the original experimental group in whom DES was tested as a postcoital contraceptive. With tightening controls and narrower indications for use of DES, the Food and Drug Administration (FDA) and congressional critics may in the near future allow its liberal use only in such extreme circumstances as rape, leaving rape victims one of the few groups for whom DES is routinely prescribed.

In light of this growing concern about the use of DES, a careful clinical review of experience with this drug in the emergency management of rape victims is in order.

Methods

For the past 12 months the Department of Family, Community. and Emergency Medicine of the University of New Mexico School of Medicine has developed a program to improve the crisis and follow-up health care of rape victims and their families at the Bernalillo County Medical Center (BCMC) in Albuquerque.

Under the new program, when a rape victim comes to the emergency room, a member of the department’s Rape Contact Team, on 24-hour call, is immediately notified. The team member comes to the emergency room and counsels the victim, preparing her for medical examination by a gynecologist and possible questioning by police. The team member stays with the victim throughout the emergency room experience. Follow-up appointments to the Family Practice Clinic are made within two to three days to assess emotional progress, physical status and compliance with medication regimens. If victims fail to keep appointments they are either given new appointments or an attempt is made to establish contact by telephone or home visit.

Gynecologic examination of rape victims in the emergency room is carried out by gynecology residents rotating through the inpatient obstetrical service. During the time covered by this article no firm criteria guided the resident’s prescribing of DES for victims of rape. Major side effects (nausea, vomiting, altered menses) and potential hazards (if pregnant) of DES therapy were generally described to each patient to whom the medication was offered. The patient herself made the final decision concerning its use. When prescribed, the dose of DES was 25 mg given orally twice a day for five days. In most instances an antiemetic medication, prochlorperazine (Compazine®) or trimethobenzamide (Tigan®), was prescribed prophylactically to diminish nausea.

Rape Contact Team members kept careful records of 150 consecutive rape victims treated at the BCMC. Doctors’ prescribing patterns for DES and patients’ compliance with and reaction to the prescribed drug were recorded. Since most of the patients received the full extent of their follow-up care within a week after initial emergency room contact, data on long-term reactions to DES in this population are scant and not reported here.

Results

Of the 150 rape victims seen, 87 (58 percent) did not receive (DES). The reasons are listed in Table 1.

Of the 63 victims (42 percent) for whom DES was prescribed, follow-up information on patient compliance and drug side effects was obtained in 55 (87 percent) (Table 2). In 40 of these victims (73 percent) there were substantial side effects from DES therapy. In six ( 11 percent) reactions of such severity occurred that the course of DES could not be completed despite the addition of antiemetic medication. Most patients who experienced nausea noted its tendency to subside spontaneously by the second or third day, frequently disappearing completely.

In two patients receiving prochlorperazine as a prophylactic against nausea, severe dystonic reactions developed necessitating both emergency treatment of the reaction and cessation of administration of the antiemetic drug.

Discussion

Kuchera reported the incidence of side effects in a sample of 1,000 women receiving DES as a postcoital contraceptive (few rape victims were included) to be 55 percent. These side effects consisted almost exclusively of nausea and vomiting. Such side effects occurred in a substantially higher proportion (73 percent) of rape victims receiving DES in our study.

It is tempting to speculate that the emotional upset of sexual assault magnifies the side effects of DES. However, Hall, reporting on experience with the use of DES in 71 women at a college health clinic (presumably few of the patients being rape victims), noted that in 71 percent nausea vomiting or both developed, a rate similar to our own. Spontaneous subsidence of nausea over several days has been well documented. This fact should be noted for each patient receiving DES.

An important outcome not reported in either of the above studies is the rate of failure to complete the full course of treatment with DES because of these side effects. Our services uncovered the fact that at least 11 percent of patients did not complete DES prophylaxis. This rate must be considered by physicians when recommending this medication.

The physical and emotional trauma of rape is so severe that health workers try to alleviate suffering by all possible means. This attitude has tended to favor a more liberal use of DES for rape victims in the belief that the discomfort of nausea and vomiting is a lesser evil than suffering the risk of an unwanted pregnancy and abortion.

Almost all victims taking DES voiced a strong desire to rid themselves of the physical and emotional vestiges of the sexual assault. They considered pregnancy prevention very important. In many cases, fear of pregnancy was the main reason for their seeking medical attention.

However, on follow-up visits, many victims and their health providers found that the victim’s prolonged nausea and vomiting drastically interfered with their ability to return to normal function and greatly compounded their already severe emotional distress, complicating the treatment effort.

Conclusion and Recommendations

There is no absolute indication for use of DES as a postcoital contraceptive in the emergency management of a rape victim. The decision to employ this drug must be made after allowing the patient to weigh the risk of pregnancy and abortion against the likelihood of DES side effects. The physician’s role is to offer options.

In light of the above findings we offer the following recommendations:

  • DES should be offered as an option to every fertile, unprotected female rape victim if she is seen within 72 hours of the assault, if the assailant’s penis penetrated her vaginally and if she is in the intermenstrual phase of her cycle. Though failure to find motile sperm in the vaginal aspirate or noting that the patient is near to her menses diminishes the risk of pregnancy, this risk is not eliminated. The patient should be allowed to weigh these risks and come to her own decision about taking DES.
  • Every rape victim for whom DES is prescribed should receive a simply written handout describing the drug, how it is taken, the likelihood of side effects and the potential dangers to the unborn fetus. A sample currently in use at the BCMC emergency room is provided. It should be noted that while the FDA has ordered that each prescription of DES be accompanied by a patient booklet setting out warnings and instructions in greater detail, such booklets have not yet been developed.
  • Each rape victim receiving DES should be contacted within 48 to 72 hours of beginning the medication to assess the presence and degree of side effects, the impact of DES on daily activities and feelings about continuing the medication.
  • If an antiemetic is prescribed prophylactically with DES, use of prochlorperazine should be avoided because of its relatively high rate of side effects.

The physician should offer the patient clearly understood, realistic alternatives and early, supportive, follow-up care. Doctor-patient rapport will be enhanced in this way and, should side effects to DES occur, knowledge of their presence will be shared with the physician, leaving the patient less frightened, upset and alone.

Sources

  • THE WESTERN JOURNAL OF MEDICINE, DIETHYLSTILBESTROL AND RAPE VICTIMS, NCBI PubMed PMC1237330, 1976 Oct.
  • Information sheet for rape victims about diethylstilbestrol (DES) featured image THE WESTERN JOURNAL OF MEDICINE.
DES DIETHYLSTILBESTROL RESOURCES

Market Share Liability New York Style: Negligence in the Air

In its famous Palsgraf decision, the Court of Appeals of New York faced the issue whether, given that a defendant acts negligently towards someone, this negligence gives rise to liability to an unforeseeable plaintiff. Judge Benjamin Cardozo concluded that proof of negligence in the air, so to speak, will not do. Because the defendant’s conduct did not pose an unreasonable risk of harm to the particular plaintiff, and the damage to her was unforeseeable, the fact that the conduct was unjustifiably risky to another was irrelevant.

Market Share Liability New York Style: Negligence in the Air, Missouri Law Review, Volume 55, Issue 4, Article 7, Fall 1990.

In a recent decision, the highest court of New York adopted a theory of market share liability that strays from Cardozo’s foreseeability theory. The New York court added a new twist to “traditional” market share liability and held that a defendant could be liable even if the defendant can show that it did not make the particular drug that injured the plaintiff. This Note evaluates the New York approach, with particular emphasis on the consequences of holding a defendant liable for “negligence in the air.”

I. FACTS AND HOLDING

Hymowitz v. Eli Lilly and Co. consolidates four cases in which plaintiffs alleged injury resulting from their mothers’ ingestion of the drug diethylstilbestrol (DES) during pregnancy.  Various manufacturers of the drug were joined as defendants in the underlying actions.

DES is a synthetic form of the female hormone estrogen. Production of DES is much cheaper than isolating natural estrogen. From 1947 to 1971 the drug was marketed for human miscarriage prevention.  In 1971, however, the Food and Drug Administration (FDA) prohibited the use of DES for this purpose. Studies linked the use of DES with vaginal adenocarcinoma, a form of cancer, and with adenosis, a precancerous vaginal growth, in the female offspring of DES users. Because an estimated one-half to three million women used DES during pregnancy, the potential monetary damages to users’ daughters is estimated in the billions of dollars.

Potential DES plaintiffs face a virtually impregnable bar to recovery under traditional tort principles. This bar stems from the difficulty in’ identifying a particular DES manufacturer and from the latent nature of DES injuries. It is estimated that, during the 24 years in which DES was approved for use during pregnancy, as many as 300 companies may have produced the drug. Further, DES is a generic drug, meaning that each manufacturer uses an identical formula in production. Thus, druggists usually fill prescriptions from whatever source is on hand.

The long gestation period also clouds the identification issue. The Hymowitz court stated:

Memories fade, records are lost or destroyed, and witnesses die. Thus the pregnant women who took DES generally never knew who produced the drug they took, and there was no reason to attempt to discover this fact until many years after ingestion, at which time the information is not available.

Because of the latent nature of DES injury, many DES cases are barred by the statute of limitations before discovery of the injury. The traditional New York rule was that “the limitations period accrued upon exposure in actions alleging personal injury caused by toxic substances.”  This “exposure rule” made it practically impossible for DES plaintiffs to recover. In 1986, however, the New York Legislature enacted a “discovery rule” for “the latent effects of exposure to any substance.” Thus, the statute of limitations clock does not begin to tick until discovery of the injury.

While helping DES plaintiffs, this legislative action does not resolve the identification issue. In the Hymowitz cases, the defendants moved for summary judgment on the grounds that the plaintiffs could not identify the particular manufacturer of the particular drug that purportedly injured them. In three of the four underlying actions the defendants also moved on statute of limitations grounds. The defendants alleged that a New York statute reviving causes of action for DES exposure for one year was unconstitutional. The trial court denied all motions. Particularly, on the statute of limitations defense the trial court granted plaintiffs’ cross motions, which eliminated defendants’ affirmative defense that the actions were timebarred.

On appeal, the New York Supreme Court, Appellate Division, affirmed in all respects. It certified the following question to the court of appeals: “whether a DES plaintiff may recover against a DES manufacturer when identification of the producer of the specific drug that caused the injury is impossible. The New York Court of Appeals answered yes. It held that a market share theory, using a national market for determining liability, was the appropriate method for determining liability and apportioning damages in DES cases in which identification of a particular manufacturer was impossible.

II. LEGAL BACKGROUND

The seminal case on market share liability is Sindell v. Abbott Laboratories. The fact pattern presented to the California Supreme Court in Sindell was very similar to that presented in Hymowitz. The Sindell court stated that generally there can be no liability without a specific showing that defendant caused plaintiff’s injuries. The court noted, however, this general causation rule was not without exceptions. The Sindell court proposed and adopted a new basis of liability for this situation; it based its proposal on a modification of an existing exception to the causation rule.

The first and most important exception examined by the California court was the so-called “alternative liability” theory as set forth in Summers v. Tice. In Summers, the plaintiff was negligently shot by one of two hunters using identical guns and ammunition. Although the plaintiff could not prove which of the two defendants actually caused his injury, the court held the defendants jointly and severally liable. The defendants could, however, escape liability by showing they could not have caused plaintiff’s injury. The Sindell case did not find the alternative liability theory applicable because of the large number of DES producers and because of the long latency period involved in DES claims.

The court also discussed a second exception to the traditional causation requirement, the theory of “concert of action. The Sindell court quoted the RESTATEMENT (SECOND) OF TORTS, providing that

for harm resulting to a third person from the tortious conduct of another, one is subject to liability if he

  • (a) does a tortious act in concert with the other or pursuant to a common design with him,
  • or (b) knows that the other’s conduct constitutes a breach of duty and gives substantial assistance or encouragement to the other so to conduct himself,
  • or (c) gives substantial assistance to the other in accomplishing a tortious result and his own conduct, separately considered, constitutes a breach of duty to the third person.

Because there was no evidence of an express or tacit agreement between manufacturers to engage in tortious conduct, there was no viable cause of action under the concerted action theory.

Finally, the Sindell court discussed the theory of “enterprise liability” posited in Hall v. E.L Du Pont de Nemovis & Co., Inc. In Hall, several children were injured by blasting caps. Unfortunately, the plaintiffs could not identify the specific manufacturer of the injury-causing product. The court imposed liability on the entire domestic blasting cap industry, which consisted of six manufacturers. The court specifically found that those six entities jointly controlled the risk. The court also focused on the parallel behavior present in the establishment of industry wide safety standards. Thus, “under this industry-wide liability theory, the existence of industry wide standards or practices may support a finding of joint control of risk and shift the burden of proving identification to the defendants.” This theory however, has never been adopted by any other court.

The Sindell court rejected the theory of enterprise liability, and noted that in the Hall case there were six possible manufacturers, while in the DES situation there were at least 200. Further, the court relied on the absence of concert of action for the proposition that defendants did not jointly control the risk. Also, the drug industry is monitored by the Food and Drug Administration; therefore, the industry standard is suggested by the government rather than by industry consensus.

Modifying the Summers v. Tice alternative liability theory, the California Supreme Court adopted a new theory of market share liability. The Sindell court first changed the Summers requirement that all potential defendants be before the court to a requirement that a “substantial percentage” be joined. Next, the Sindell majority held “each defendant will be held liable for the proportion of the judgment represented by its share of that market unless it demonstrates that it could not have made the product which caused plaintiff’s injuries. Thus, a defendant can exculpate itself by showing it could not have made the injury-causing product. The court rationalized that under this approach, each manufacturer’s liability would approximate its responsibility for the injuries caused by its own products.

The Sindell decision left open the question whether the liability imposed would be joint and several or several only. In Brown v. Superior Court, the California Supreme Court resolved this ambiguity, by providing that each defendant’s liability under market share is several only. An individual manufacturer’s liability cannot be inflated to allow for the full recovery of plaintiffs’ injuries. Thus, in California liability cannot exceed a given company’s market share.

The Wisconsin Supreme Court adopted its own version of market share liability in Collins v. Eli Lilly Co. It declined to follow the Sindell approach, and held instead that “unalloyed market share theory does not constitute the most desirable course to follow in DES cases because the theory, while conceptually attractive, is limited in practical applicability. By practical inapplicability, the court was referring to “the practical difficulty of defining and proving market share.”

The Wisconsin approach begins with the general proposition that each defendant contributed to the risk of injury to the public … thus each defendant shares, in some measure, a degree of culpability in producing or marketing … a drug with possibly harmful side effects. Under this approach, the plaintiff’s prima facie case consists of establishing by a preponderance of the evidence that a defendant produced or marketed the type (e.g., color, shape, markings, size, or other identifiable characteristics) of DES taken by the plaintiff’s mother.

Once the plaintiff has alleged a viable cause of action, the burden of proof shifts to the defendant to prove by a preponderance of the evidence that it did not produce or market the subject DES either during the time period the plaintiff was exposed to DES or in the relevant geographical market area in which the plaintiff’s mother acquired the DES. The Collins court held that determination of liability was a jury question to be answered in the context of Wisconsin’s comparative negligence doctrine. According to the court, market share remains an important factor for the jury’s consideration.  The goal of the Wisconsin approach appears to be to allow the jury to hold a defendant liable in proportion to the amount of risk it created that the plaintiff would be injured by DES. This risk-based approach resembles market share liability only when a jury is allowed to consider market share in making its assessment of the proportion of risk of injury for which a defendant is liable.

Shortly after Collins, the Washington Supreme Court adopted another version of DES market share liability in Martin v. Abbott Laboratories. The Washington version, styled “market share alternative liability,” claims justification in that “each defendant contributed to the risk of injury to the public and, consequently, the risk of injury to individual plaintiffs.” The Washington court did leave defendants an out: Individual defendants are entitled to exculpate themselves from liability by establishing, by a preponderance of the evidence, that they did not produce or market the… DES taken by plaintiff’s mother . . .

An interesting aspect of the Washington methodology is that defendants who fail to exculpate themselves are “presumed to have equal shares of the market and are liable for only the percentage of plaintiff’s judgment that represents their presumptive share of the market.” A defendant may rebut this presumption by introducing evidence to establish respective market share. If proven, a particular defendant is liable only for the percentage of the total judgment corresponding to the company’s market share. The liability of unexculpated defendants, however, is inflated to allow for a 100% recovery.

The Washington Supreme Court further developed its theory in George v. Parke-Davis, a subsequent DES decision. First, the determination of market share is a question of fact in each case. Second, depending on the circumstances of a particular case, the relevant market may be as small as the local pharmacy or as large as the country. The court stated “the relevant market for determining liability should be as narrow as possible”.

III. THE INSTANT DECISION

A. Rejection of Accepted Tort Doctrine

Judge Wachtler, author of the majority opinion, began by rejecting the established tort doctrines of alternative liability and concerted action: He stated “we agree with the near unanimous views of the high [s]tate courts that have considered the matter that these doctrines in their unaltered common-law forms do not permit recovery in DES cases.

Relying on Summers v. Tice, the Hymowitz court stated the rule of alternative liability as “where two defendants breach a duty to the plaintiff, but there is uncertainty regarding which one caused the injury, the burden is upon each such actor to prove that he has not caused the harm. The court stated that “the central rationale for shifting the burden of proof in such a situation is that without this device both defendants will be silent, and plaintiff will not recover; with alternative liability, however, defendants will be forced to speak, and reveal the culpable party, or else be held jointly and severally liable themselves.

The court postulated that in order to invoke the doctrine of alternative liability, the defendant must have better access to information than the plaintiff, and all possible tortfeasors should be joined in the action. Further, the court stated “alternative liability rests on the notion that where there is a small number of possible wrongdoers, all of whom breached a duty to the plaintiff, the likelihood that any one of them injured the plaintiff is relatively high, so that forcing them to exonerate themselves, or be held liable, is not unfair.

The Hymowitz court ultimately held the large number of potential tortfeasors and the long time period between ingestion and injury created problems for this traditional tort theory. Defendants did not have the requisite better access to information, and it was virtually impossible to have all possible producers before the court. The court seized also on the issue of fairness, holding “while it may be fair to employ alternative liability in cases involving only a small number of potential wrongdoers, that fairness disappears with the decreasing probability that any one of the defendants actually caused the injury.” In DES litigation the chance a particular defendant actually caused the injury in question is often very remote. Therefore, alternative liability provides no relief.

Next, the court dealt with the theory of concerted action. Analogizing to drag racing cases, it stated the theory provides for joint and several liability on the part of all defendants having an understanding, express or tacit, to participate in ‘a common plan or design to commit a tortious act.

The court conceded the drug companies had engaged in parallel conduct in producing DES from an identical formula. There was, however, no evidence of any agreement to market DES in an unsafe manner.9 ” The court concluded “parallel activity, without more, is insufficient to establish the agreement element necessary to maintain a concerted action claim.”

Although the traditional common law doctrine provided plaintiffs with no relief in Hymowitz, the court rationalized that “judicial action is … required to overcome the inordinately difficult problems of proof caused by contemporary products and marketing techniques.”‘ Thus, the court opened the door for the imposition of market share liability.

B. Market Share Liability

In looking to non-traditional forms of relief, the Hymowitz court stressed that in the DES situation, “it is more appropriate that the loss be borne by those that produced the drug for use during pregnancy, rather than by those who were injured by the use, even where the precise manufacturer of the drug cannot be identified in a particular action.” Policies of fairness and justice mandated judicial relief.

First, the court had to deal with its previous DES decision in Bichler v. Eli Lilly & Co. Some commentators interpreted Bichler to create a modified form of the concerted action doctrine. In Bichler, the court submitted jury instructions substituting “conscious parallel activity by manufacturers” for the traditional common law requirement that a plaintiff prove “actual or tacit agreement to participate in a common plan to commit tortious behavior.” Because of the defendant’s failure to object, “the modified concerted action theory became the law applicable to that particular case.”

The Hymowitz court, however, refused to adopt this modified concerted action theory as the general law of the state. It held

inferring agreement from the fact of parallel activity alone improperly expands the concept of concerted action beyond a rational or fair limit; among other things, it potentially renders small manufacturers, in the case of DES and in countless other industries, jointly liable for all damages stemming from the defective products of an entire industry.

Parallel behavior is too common in modern industry to warrant the imposition of liability.

Finally, the Hymowitz court turned to the concept of market share liability. After examining the various forms of market share liability adopted in other jurisdictions, the court posed its own solution. Relying primarily upon California’s experience, the court concluded “a market share theory, based upon a national market,” provided the practical solution. The court explicitly rejected the Wisconsin “assessment of risk” approach, finding this methodology would prove too burdensome and inconsistent over the long run.

The court realized the adoption of a market share liability theory using a national market would probably result in a disparity between an individual manufacturer’s liability and the actual injuries caused by that manufacturer in New York. Thus, the Hymowitz policy differs from the Sindell policy. Liability is not expected to correspond with causation over the long run of cases. Further, the court recognized that the use of a national market would not necessarily result in liability in proportion to the risk created by a defendant towards a particular plaintiff. The Hymowitz court chose “to apportion liability so as to correspond to the overall culpability of each defendant, measured by the amount of risk of injury each defendant created to the public-at-large.”

C. The “New Twist”

In contrast to previous versions of market share liability, the Hynowitz court refused to excuse a defendant from liability upon a showing that it could not possibly have manufactured the particular drug which injured the plaintiff.  The court stated that because liability here is based on the over-all risk produced, and not causation in a single case, there should be no exculpation of the defendant who, although a member of the market producing DES for pregnancy use, appears not to have caused a particular plaintiff’s injury. The majority rationalized that it is merely a windfall for a producer to escape liability solely because it manufactured a more identifiable pill, or sold only to certain drug stores. These fortuities in no way diminish the culpability of a defendant for marketing the product, which is the basis of liability here. The majority did concede that a defendant could not be held liable if it did not make DES for use during pregnancy.

Finally, the Hymowitz court found DES producers severally liable, not jointly and severally liable as had other jurisdictions. Liability should not be inflated when all participants in the market are not before the court in a particular case. The court realized its rule would result in some plaintiffs failing to recover their total damages. The court explained that because it refused to allow a defendant exculpation from liability, it would not be fair to increase a defendant’s liability beyond its fair share of responsibility.

D. Judge Mollen’s Opinion

Judge Mollen concurred in two of the underlying cases and dissented in part in the remaining two. Mollen agreed with the majority that market share liability based on a national market was the proper theory for the plaintiffs to pursue. He would, however, allow exculpation of a defendant who could prove, by a preponderance of the evidence, that it did not manufacture the particular pill taken by the plaintiff’s mother. Further, he would allow joint and several liability in order to ensure that a particular plaintiff obtains full relief.

Judge Mollen noted that in the California, Wisconsin, and Washington approaches, a defendant could exculpate itself by proving it could not have made the specific drug taken by the plaintiff. He realized “to preclude exculpation would directly and unnecessarily contravene the established common-law tort principles of causation.” Mollen contended the majority “provides DES plaintiffs with an unprecedented strict liability cause of action.” He maintained the majority’s rationale is “unfair and inequitable” to those defendants who could prove they did not manufacture the drug in question.  In Mollen’s opinion, the majority was merely adopting the Bichler “modified concerted action” theory which they explicitly purported to reject in their opinion.

Judge Mollen appears to embrace the Sindell approach. He advocates

the shifting of the burden of proof on the issue of causation to the defendants and he would impose liability upon all of the defendants who produced and marketed DES for pregnancy purposes, except those who were able* to prove that their product could not have caused the injury.

Judge Mollen further advocates imposing joint and several liability on those defendants who are unable to exculpate themselves. Mollen’s version of market share liability differs from Sindell in this respect. Joint and several liability ensures plaintiffs a full recovery for their injuries.

This procedure also provides defendants with an incentive to implead DES manufacturers not joined by the plaintiff. This opportunity reduces unfairness to innocent defendants. Mollen claims this approach furthers the “valid public policy of imposing the burden of bearing the cost of severe injuries upon those who are responsible for placing into the stream of commerce the causative instrumentality of such injuries. Finally, Judge Mollen concludes the majority engages in judicial legislation by eliminatinh fundamental causation requirements.

IV. COMMENT

This Note uses the policy behind tort law and products liability as a framework for analysis. This policy framework warrants a terse review. Further, the Note examines attempts to expand market share liability outside the DES arena, and evaluates a potential legislative solution.

A. Policy Framework

Compensation and deterrence are the two most widely announced purposes underlying tort law. Other frequently mentioned purposes are the assessment of moral blame in the eyes of society, and the punishment of wrongdoers. A major purpose of the cause in fact requirement in tort law is to limit the scope of potential liability. Professor David Fischer writes that the “cause-in-fact requirement is one way in which the law limits the scope of liability and attempts to avoid discouraging socially desireable activity.”

There are six generally recognized goals of a strict products liability regime. These goals include

  1. compensation (or loss spreading);
  2. deterrence;
  3. encouraging useful conduct;
  4. overcoming proof problems;
  5. protection of consumer expectations;
  6. and cost internalization.

The compensation goal is based on the premise that in our modern society injuries to individual consumers caused by the use of complex products are inevitable. Because of the gravity of potential injury, it is fair to impose liability on the manufacturers of these products who can, in turn, shift the loss back to consumers via price increases or insurance.

The deterrence goal rests on the proposition that the threat of liability motivates manufacturers to make safer products. Strict liability is believed to be a stronger deterrent than negligence. Under a negligence standard a manufacturer is held to a reasonable person benchmark, while the strict liability standard may require a manufacturer to go beyond this reasonable person criterion if the cost of added safety is less than the cost of potential liability.

The third goal, and perhaps the most important for purposes of analyzing the New York version of market share liability, is encouraging useful conduct. The deterrence and compensation goals nearly always indicate liability. Yet, until the New York version of market share liability:

no court has imposed the liability of an insurer on manufacturers by requiring them to pay for all harm caused by their products. This is because of the fear that such absolute liability would place unreasonable burdens on manufacturers and discourage them from producing useful products. The policy of avoiding over-deterrence by balancing the needs of defendants against needs of plaintiff is clearly at work, although it is seldom articulated.

The fourth goal of products liability law is to help plaintiffs overcome difficult proof problems. Often the defendant is in a much better position than an individual plaintiff to prove fault or lack of fault. Some commentators conclude that the market share liability theory reflects courts policy judgment that as between an innocent plaintiff and defendants who are allegedly guilty of some wrongful conduct, the plaintiff should prevail-even if the alleged (not necessarily established) conduct in question did not cause .the plaintiff’s injury. In products liability actions courts often simplify the plaintiff’s prima facie case or shift the burden of proof on an issue to the defendant.

The final two commonly articulated goals of product liability law include the protection of consumer expectations and the policy of cost internalization. The consumer expectation policy is grounded in the notion that manufacturers induce consumers to rely on safe products, thus the consumer should be protected from hidden perils. The cost internalization goal depends on manufacturers passing liability costs back to consumers, who can then make intelligent purchases based upon the true costs of products.

B. Policy Implications of New York’s Version of Market Share Liability

The traditional tort requirement of causation in fact fails to further tort goals of deterrence and compensation. Professor Fischer provides the following illustration:

Suppose a falling tree that had been struck by lightning injured plaintiff. If plaintiff were able to establish that a railroad company was negligent in failing to equip its locomotive with a whistle, a court could further the tort policies of compensation and deterrence by imposing liability for plaintiff’s injury upon the railroad company, even though no causal connection existed between the company’s negligence and plaintiff’s injury. As long as the railroad company understood that liability was being imposed upon it because of its negligence, it would have an incentive to equip its locomotives properly in the future. At the same time, requiring the railroad company to compensate the injured party would further society’s interest in compensating accident victims.

Thus, market share liability fails to profoundly effect these goals.

The goal of assessing moral blame flounders in the context of “traditional” market share liability. The plaintiff may not have even joined the culpable defendant. This problem is magnified under the New York theory, where there certainly will be cases where a defendant could exculpate itself if given an opportunity. The policy of assessing moral blame is further watered down as courts decrease the threshold of “substantial market share” below the ninety percent level. This problem is intensified if market share is expanded to industries which, unlike the DES market, are not concentrated in a relatively few firms.

Perhaps the most profound policy effect of market share liability transpires in the area of encouraging useful conduct, or avoiding overdeterrence. The consequences of over-deterrence include disincentives for safety to unsafe manufacturers, and a reluctance by “leading edge” companies to introduce new products for fear of potential liability. “By apportioning damages throughout an industry solely on the basis of market shares and irrespective of safety efforts, it enables unsafe manufacturers to spread the burden of their accident costs and thereby creates disincentives for safety.” Further,

it has also been pointed out that imposing the market-share theory in a strict liability tort case gives rise to a form of absolute liability by relieving the plaintiff of proving defendant’s breach of duty and by guaranteeing plaintiff’s proof of causation, which ‘forces an industry into the position of an insurer of a product.

In reflecting on the over-deterrence issue, liability expert Peter Huber asks and answers the question who fled most quickly from the baying tort pack? Those quickest on their feet, of course-the person of action, the company of initiative, the mover, the shaker, and the doer. In characterizing the damper placed on innovation by excessive tort liability, he states in the very markets where the legal pursuit was the most intense … the mood among suppliers became most sullen, hostile, defensive, and then coldly stagnant.

As an example, Huber states “research expenditures by U.S. companies working on contraceptives peaked in 1973 and plummeted 90% percent in the next decade.” Huber quotes the president of a major pharmaceutical company, reflecting on the amount of litigation and asking “who in his right mind would work on a product today that would be used by pregnant women? Society suffers because “it is the innovative and unfamiliar that is most likely to be condemned.”

Empirical evidence on the over-deterrence effect is difficult to find. According to one author, “the inquiry is enormous because virtually every corner of society has been reached by the liability revolution, and frustrating because each story is unique, with much of the evidence anecdotal in nature and hard to document or quantify.” In the pharmaceutical industry, much of the evidence that is available centers around the highly visible areas of contraception and vaccines. It is safe to say, however, that the number of product liability lawsuits filed in the U.S. is increasing at a staggering rate. Between 1974 and 1988 the number of product liability lawsuits filed in federal district courts increased by 983 percent.

Because of the limited availability of concrete evidence, it becomes necessary to infer over-deterrence from certain market characteristics. For instance,

in 1980, experts writing in International Family Planning Perspectives predicted that long-acting hormonal rings, vaginal rings, new injectable preparations, postaglandins to induce early abortions, IUDs causing less bleeding and pain, and cervical caps are in advanced field trials with thousands of women, and should be widely available in the contraceptive industry within the next three to five years.

Though some of these products are now available in Europe, nine years later not one is available in the U.S. A plausible explanation for the availability of the drugs in Europe and not in the United States is the liability crisis.

C. Attempts to Expand Market Share Liability Outside the DES Arena

Courts limit the doctrine of market share liability to DES cases. Innovative plaintiffs attorneys, however, diligently attempt to apply market share liability outside the DES context. Examples of actual attempts at expansion range from vaccines to asbestos and even to a ruptured breast prosthesis. The Sindell court implied that “the market share theory… conceivably could apply to all potentially harmful fungible products made from an identical formula.” Thus, market share liability could conceivably embrace “the manufacturing and marketing of cigarettes, food additives, generic drugs,  asbestos, pesticides, aluminum wire, industrial waste, and products that cause environmental pollution.” Fortunately, at this juncture attempts at expansion fail.

A recent New Jersey case illustrates careful reasoning by a court in refusing to expand market share liability. In Shackil v. Lederle Laboratories, the plaintiffs filed a medical malpractice and products liability action arising out of the 1972 inoculation of an infant plaintiff with what is commonly known as the DPT vaccine. The plaintiffs could not identify the specific manufacturer, so attempted to invoke market share liability.  In refusing to accept the theory, the court rationalized that the imposition of market share liability would frustrate public policy and public health considerations by “threatening the continued availability of needed drugs and impairing the prospects of the development of safer vaccines. The court also paid heed to the fact that recent market trends threatened the supply of DPT and that due to extreme liability exposure there were only two current producers of the drug. While the Shackil court found no liability, it addresses the potential problems inherent in imposing too much liability on an industry as vital to our health and welfare as the drug industry.

D. Legislative Question

Some commentators suggest a legislative or administrative compensation plan when injured persons cannot identify the specific manufacturer responsible. Suggested alternatives include:

  1. a limited no-fault product liability fund for plaintiffs unable to identify the manufacturer of a generic product that produced a latent injury;
  2. suits against the federal agency responsible for regulating the particular industry using the Federal Tort Claims Act and the Administrative Procedure Act;
  3. ad hoc congressional responses to mass injuries caused by products of unidentifiable manufacturers;
  4. legislation designed to hold certain industries liable through trade associations for all injuries caused by those industries’ products whenever the manufacturer of an injury-causing product is not identifiable;
  5. a no-fault compensation system for persons injured by DES which would be funded by a tax imposed upon all manufacturers who produced DES for use as a miscarriage preventative;
  6. and a toxic tort compensation system not limited to a single industry or a single type of product-injury but designed to deal with the toxic tort problem as a whole.

Schwartz and Mahshigian suggest a particularly appealing legislative solution which grasps the following general principles:

  1. the tort system should guide recovery when a particular defendant can be identified;
  2. in non-identification cases, the claimant should be required to show fault, causation, damages, and a good-faith, genuine attempt to identify the manufacturer
  3. legislation should penalize plaintiffs and counsel who falsely identify a defendant … including defendant’s legal costs and a possible civil fine;
  4. the legislation should strongly emphasize causation-that the product actually caused plaintiff’s injury;
  5. and damages should be limited to the claimant’s true excess economic losses, which means no damages for pain and suffering.

Specific provisions of the Schwartz and Mahshigian plan remedy many problems cited in this Note. First, this scheme places the burden of proof on the defendant only when information is in the defendant’s control.211 Second, the plan provides that all manufacturers of DES should contribute to compensation paid to plaintiffs, calling this provision “fairer than the random targeting of defendants that occurs under current judicial theories.” Third, payment by the individual manufacturers “furthers the cause of effective deterrence of (and where appropriate, penalty for) tortious behavior.” Fourth, a properly applied legislative solution would lower the administration costs of the present tort system. Finally, limiting recovery to economic damages lessens the burden on manufacturers. This relief conceivably inures to the benefit of society in the form of lowered prices and increased innovation.

Another attractive legislative solution is the adoption of a federal products liability statute that pays more credence to FDA approval. An Institute of Medicine study recently advocated that, as a general matter, there be no liability for design defect or inadequate warning if the FDA has reviewed and approved the contraceptive product or the warning and has addressed the characteristics of the product that caused the plaintiff’s injury. The defense should not be available if the manufacturer withheld relevant information from the FDA in the approval process or if information developed after approval was not reviewed by the FDA for the purpose of determining whether the product or its labeling should be changed.

The added certainty which a uniform statute provides would allow manufacturers to divert more funds into the research and development area, and would allow the introduction of innovative new products without fear of excessive liability.

V. CONCLUSION

Looked at from a societal perspective, market share liability fails horribly. It merely perpetuates the overall liability crisis in America. Society suffers from increased prices, decreased safety, and a reluctance to market beneficial new products. This crisis begs for a return to traditional tort theory.

The New York version of market share liability assumes a perfect world. It requires uniformity to meet its initial goal of averaging. Thus, it only “works” if all fifty states apply the same rationale. Absent uniformity it becomes grossly unfair to defendants. Given that at least six states explicitly reject market share liability, and that only a half dozen others adopt the theory, the prospect of uniformity is slim. Therefore, if one buys into the market share concept, the only way to assure perfect compliance is through comprehensive federal legislation.

The Hymowitz decision allows “offensive” use of market share liability even when the defendant DES manufacturer can prove that it absolutely did not manufacture the particular drug taken by the plaintiff. Extending this logic to its natural conclusion, perhaps a defendant should be able to use market share “defensively” when the plaintiff can identify the culpable manufacturer. Thus, a defendant marketing five percent of the DES produced for use during pregnancy would only be liable for five percent of plaintiff’s damages even when identified as the culpable party. The overall ‘liability of a particular defendant would then coincide perfectly with culpability. To hold otherwise “transforms the market share liability theory into a lottery based on the fortuity of the availability of evidence in a particular case. The outcome, of course, is absurd.

Mike D. Murphy, 1990.

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More DES DiEthylStilbestrol Resources

The Relevancy of Drug Efficacy Evidence in Strict Liability Actions

INTRODUCTION

Diethylstilbestrol (DES), a synthetic estrogen widely prescribed in the past for the prevention of miscarriage is currently the subject of much drug litigation. The association between clear-cell adenocarcinoma of the vagina in young females, a rare cancer which was virtually unknown before the use of DES, and prenatal exposure to DES is firmly established. It is estimated that in the female DES-exposed population, four in one thousand women will develop clear-cell adenocarcinoma. Almost fifty deaths have resulted from prenatal exposure to DES.

The Relevancy of Drug Efficacy Evidence in Strict Liability Actions: Needham v. White Laboratories,
Inc, The John Marshall Law Review, Volume 14 | Issue 3 Article 2, Summer 1981.

DES daughters, and DES sons as well, suffer from a variety of maladies which presently are considered benign, but are suspected to be precancerous. For example, it is estimated that adenosis, the abnormal presence of benign glandular tissue in the vagina, occurs in eighty to ninety percent of the female population exposed in utero to DES, yet adenosis is found histologically in over ninety-seven percent of DES daughters who have adenocarcinoma of the vagina.  DES daughters also may develop various abnormalities of the cervix. Recent research reveals that a number of DES sons also suffer from abnormalities which may result in sterility, and a preliminary study suggests the need for research on whether in utero DES exposure may be associated with a risk for testicular cancer.

DES mothers, also, are subject to an increased risk of endometrial cancer. In addition, a recent follow-up study of DES mothers shows that they have an increased risk of breast cancer. Researchers’ views differ as to the significance of this increase, however, animal studies demonstrate that estrogen increases the frequency of carcinomas of the breast, cervix, vagina, kidney, and liver.

DES daughters have instituted a number of legal actions against drug manufacturers. DES mothers who were unknowing participants in a 1953 study to determine the effectiveness of DES are litigating a class action suit against the University of Chicago Lying-in Hospital and Eli Lilly Company. At least one suit has been filed by a DES son who is suffering from testicular cancer.

DES litigation has fostered the articulation of new theory, as well as the creative application of established theory, in the area of tort law. The majority of the decisions favor DES defendants. The recent decision of the Seventh Circuit in Needham v. White Laboratories, Inc., reversing a jury’s determination of drug manufacturer liability, deals a drastic blow to drug injured plaintiffs seeking to hold drug manufacturers strictly liable in tort. The reversal is significant because Needham is the first appellate reversal of a DES plaintiff’s jury verdict and its impact on drug litigation is far reaching. This article will analyze the Needham decision within the context of strict liability principles appropriate to the drug industry.

Needham v. White Laboratories, Inc.

Plaintiff Needham’s mother ingested dienestrol, a synthetic estrogen similar to DES, while she was pregnant with the plain- tiff. At the age of twenty, plaintiff discovered she had the rare clear-cell adenocarcinoma of the vagina, which made surgical removal of all her reproductive organs necessary. Plaintiff sued White Laboratories, the manufacturer of dienestrol, on theories of negligence, strict liability in tort, and fraud and deceit. Plaintiff’s strict liability claim was based on two theories: failure to properly warn of the risk of cancer from exposure to dienestrol; and production of a drug which was defective in that it was useless and unreasonably dangerous in the treatment of threatened or habitual abortion. Plaintiff’s two theories of negligence were based on defendant’s failure to test dienestrol in accordance with 1952 medical research standards and to warn of its dangers.

Before instructions were given to the Needham jury, the Illinois Supreme Court held in Woodill v. Parke Davis Co , that a manufacturer is strictly liable for failure to warn of a risk of injury if the manufacturer knew or should have known of the product’s danger. The Woodill majority asserted that it was not imposing a negligence standard. Although a knowledge requirement injects an element of fault which, in theory, is absent in strict liability, in the court’s view, failure to warn based on strict liability remains separate and distinct from failure to warn based on negligence. The court did not clearly define this difference; however, given its extensive reliance on comment k to section 402A of the Restatement (Second) of Torts,  it seems reasonable to presume that the comment may provide an explanation.

Comment k and Evidence of Efficacy

The comment k exception to strict liability is created for unavoidably unsafe products, and it applies particularly to drugs, which in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. The sale of such products may be justified, provided a warning is given when necessary, because the benefit of using the product appears to outweigh the attendant risk.

Relying on both Woodill and the comment k strict liability exception for unavoidably unsafe products, the district court in Needham allowed plaintiff to present evidence of dienestrol’s ineffectiveness to counter defendant’s reliance on the comment k exception to strict liability. The district court reasoned that if comment k did not apply because the sale of dienestrol was not justifled–i.e., it had no apparent usefulness to outweigh any risk of harm-then the defendant could be liable for marketing the drug even if the plaintiff could not prove the defendant knew it was dangerous and yet failed to give a warning. The relevant issue would be whether defendant knew or should have known that the drug was ineffective or not apparently useful, not whether defendant knew it was dangerous. The district court also noted that evidence of dienestrol’s ineffectiveness was relevant to plaintiff’s alternate theory of strict liability that dienestrol was defective and unreasonably dangerous because it was ineffective and caused cancer.  The essence of this alternate theory is that dienestrol was not fit for its intended use.

The Seventh Circuit’s View

The jury returned a general verdict against the defendant and assessed damages of $800,000.  On appeal, the Seventh Circuit reversed and remanded for a new trial, holding that evidence of dienestrol’s effectiveness or ineffectiveness was irrelevant and prejudicial. The court’s decision was premised on the notion that Illinois recognizes two types of strict liability drug actions involving warnings which are set forth in comments j and k to section 402A: complete failure to give a warning; and failure to give an adequate warning. In the Seventh Circuit’s view, comment k contemplates only the latter instance in which some warning is given but is inadequate. Here, a manufacturer is entitled to comment k protection only if the product’s benefits outweigh its risks. If no warning at all is given, comment j governs the action. The court reasoned that efficacy evidence is relevant only in a comment k case because, in that instance, the drug’s benefits must be balanced against its risks. In a comment j case, where no warning is given, efficacy evidence is irrelevant, according to the court, because the manufacturer’s liability turns on whether it had knowledge of the risk about which it failed to warn. Concluding that the defendant in Needham failed to give a warning of the risk of cancer from ingesting its product, the circuit court held that comment j governed, and evidence of dienestrol’s ineffectiveness was therefore irrelevant and prejudicial to the defendant. The court also asserted that Illinois law did not support plaintiff’s alternate theory of strict liability, and accordingly efficacy evidence was not relevant to this theory.

The court’s decision rests on an erroneous interpretation of Woodill. The court characterized Woodill as a comment j case and announced flatly that Illinois had not yet decided a comment k case. In fact, comments j and k may be read together for the purpose of determining whether any given case should be governed by a strict liability standard. Thus, in actions against the manufacturers of concededly beneficial drugs, liability must be premised on defendant’s knowledge of the risk of injury. These cases, unlike Needham, have not involved a challenge to the claimed benefits of the drug. In the absence of such a challenge, an initial presumption that benefits outweigh risks is made. Once this presumption is made, the manufacturer’s liability for failure to warn, under comment k, turns on whether the drug is properly prepared and accompanied by warnings of known dangers. If the drug is accompanied by a warning of known risks of injury and is properly prepared, the manufacturer is not liable for harm caused by its dangerous product. If, on the other hand, the manufacturer knows or should know of the drug’s risks, and fails either to warn or to properly prepare the drug, the drug is considered to be unreasonably dangerous and the manufacturer is liable for harm caused.

Where the assumption that a drug is beneficial is challenged, as in Needham, the court must initially determine whether or not the drug’s usefulness is outweighed by its risks. Efficacy evidence is crucial to this determination. If the drug’s risks outweigh its usefulness, the manufacturer will be liable for its unreasonably dangerous product irrespective of its ignorance of the risk of injury.

The Seventh Circuit failed to note that Illinois courts had never been confronted with a strict liability, failure to warn action involving a challenge to the drug’s usefulness. Whether comment k protection from strict liability should be extended to such a case had never been called into question. Comment k imposes a knowledge of risk requirement for failure to warn cases which involve beneficial drugs. Thus, comment k expresses a policy of not imposing strict-where knowledge is irrelevant-liability where a manufacturer has undertaken to supply the public with a useful drug. Where, however, the drug manufacturer has not marketed a useful drug, the rationale for protecting the manufacturer from strict liability is absent. Public policy negates the argument that comment k protection may be invoked before it is established that defendant marketed a relatively beneficial drug. But for the principal case, no Illinois precedent would support such an expansive interpretation of comment k.

THE NATURE OF THE DRUG INDUSTRY

High Profits; Few Losses

An understanding of the nature of the drug industry is essential to understanding the legal, factual, and policy issues that the Needham cases raises. The drug industry has been described as one of both high profits and high returns. During congressional hearings in 1972, the drug industry was characterized as practically unique in that 1osses or even low profits, are virtually unheard of among larger companies. Although drug companies attempt to justify high profits by pointing to the extreme risks inherent in the development of new drugs, critics note that if extreme risks justify high profits, one would expect to see “occasional losses” by some firms instead of “consistently high industrywide profits.

The fear that imposing strict liability on the sellers of drugs would result in depriving consumers of essential drugs, has little basis in reality. One commentator has argued that this fear should not shape the development of strict liability law in the absence of substantial empirical supporting data showing that the profit margin in the drug industry is so low that the industry could not bear the cost of compensation for the injuries it produces. This argument is especially persuasive when the industry produces, promotes, and obtains large profits from a drug like DES, whose efficacy and concommitant benefits are questionable, and which is also capable of causing serious injury. Such products are particularly appropriate subjects for strict liability.

“Me Too” Practices

Another unusual feature of the drug industry is the “me too” practice of developing new drugs. “Me too” drugs are typically made by slightly deviating from the molecular make-up of an already marketed drug. Molecular manipulation is of no significant therapeutic value. The practice does, however, enable a manufacturer to market a theoretically “new” drug without violating a patent or obtaining a licensing agreement from the manufacturer who invented the original product. Thus, drug companies expend considerable research money to develop drugs which vary only slightly from the original product.

The result is a proliferation of company trade names for essentially one product. The Health, Education and Welfare (HEW) task force on prescription drugs determined that important new chemical entities represent only a fraction, perhaps 10-20%, of all new products introduced each year, while the remainder consist merely of minor modifications of combination products. The task force concluded that many of the drug industry’s research and development activities would appear to provide only minor contributions to medical progress. A more important concern, especially in the case of DES-related products, is that a single defect in the original drug may be common to all similar products subsequently manufactured.

DES, dienestrol, and related DES products are poignant examples of drug industry “me too” practices. DES was unpatented by its original inventor. In 1941, twelve drug companies submitted a joint clinical file to the Food and Drug Administration (FDA) as part of their New Drug Application (NDA) request for permission to market DES. These companies also agreed on common chemical standards, uniform labeling, and product literature for the drug to be manufactured by each of them. The companies did not request permission to market DES to prevent threatened or habitual abortion until 1947.

In 1946, White Laboratories obtained permission to market dienestrol for the same use as DES.64 DES and dienestrol are virtually identical in action and toxicity; dienestrol, specifically marketed to be competitive with DES, was described by the former medical director of White Laboratories as a “me too” drug.

In 1948, a year after other companies received permission to market DES for use in the treatment of threatened abortion, White Laboratories submitted a supplemental NDA requesting permission to market dienestrol for the same use in pregnancy. Its intent in marketing dienestrol was to compete with DES; dienestrol had no advantages over DES for use in pregnant women. Moreover, when White Laboratories requested permission to market dienestrol, it did no independent testing of dienestrol’s safety in pregnant women or their offspring. The supplemental NDA contained only two summaries of case reports by two different doctors to show that dienestrol would do what White Laboratories claimed it could do-prevent habitual or threatened abortion. These case reports were characterized by two eminent researchers as grossly inadequate demonstrations of these claims.

The FDA Then and Now

White Laboratories argued that FDA approval of dienestrol absolved the company of responsibility for failure to test dienestrol adequately before marketing it. While some authority exists for this proposition, most courts have held that FDA approval does not discharge the obligation of the drug manufacturer to test adequately for and warn of its product’s risks of danger.

The premise underlying the argument that FDA regulations define only minimal standards, may well be an accurate assessment of the FDA’s role in the 1950s and today. Prior to 1962, a drug manufacturer’s NDA was automatically approved if the FDA did not object to the marketing of the drug. While the FDA must now act positively to approve a drug for marketing, it still only reviews a report of data provided by the drug manufacturer. The FDA does not test the drug independently, and the drug manufacturer, consequently, has complete control over what data is submitted. While the FDA may refuse to approve of a drug until a manufacturer performs additional tests, the ultimate responsibility for providing the clinical data upon which the agency will make its final determination rests with the party who has the greatest interest in a favorable response.

Data submitted by drug manufacturers has often been criticized by the FDA as scientifically inadequate; some has even been shown to be fraudulently concealed or rigged. Clinical investigators hired by drug companies to investigate their drugs have also been criticized as tending to skew data in favor of their employers. Many articles extolling a drug’s virtues or minimizing its harmful effects, which are published in respectable medical journals, have been sponsored by the drug company that manufactured the drug. A substantial number of these articles have been written within the confines of the pharmaceutical houses concerned. Moreover, medical journals rely on drug advertising as a major source of financing. Some medical journals which, by virtue of their ownership, are captives of certain drug houses, have printed inaccurate articles on the miraculous effects of new drugs. Once a drug has been authenticated by publication, the drug manufacturer cites the article as authority for its advertising claims.

Promotional Practices

Not only is the FDA dependent upon drug manufacturers for information about their drugs, but the prescribing physician also relies on the drug manufacturer for information about a drug’s safety and instructions for use. Medical practitioners simply cannot keep abreast of numerous medical articles, scattered in hundreds of journals, on each new drug which appears on the market. Consequently, doctors rely on product information supplied by the drug companies through advertising in drug brochures and medical journals, and detail men who personally visit a doctor to promote a specific drug.

Advertising

The proliferation of “me too” drugs, each with its own brand name, makes advertising the important variable in the fight for increased sales. Drug companies spend enormous amounts of money to influence a doctor’s choice of a brand name drug. A brand name often is easier to remember than the more complex generic name. Drug manufacturers inundate doctors daily with a “torrent of new drug advertising” which is “confusing” and “misleading.” Frequently, warnings appearing in a brochure about drug side effects are tucked neatly away behind a “stream of literature which extols the claimed virtues of the drug so glowingly that it takes attention away from the hazards of the drug. The physician simply is “bombarded with seductive advertising which fails to tell the truth;” which often misleads him or her to prescribe a new drug without adequate information about possible side effects and without any “solid clinical evidence that the drug is effective or even as safe as the advertisers claim.”

The advertising practices of DES manufacturers are subject to these criticisms. Claims of DES’s safety and effectiveness in the treatment of threatened and habitual abortion abounded in advertisements within reputable medical journals. Some advertisements recommended DES as a routine prophylaxis in all pregnancies.

Detail Men

Since drug manufacturers daily send physicians more drug information than they can possibly read or remember, physicians rely on detail men for drug information.  Detail men frequently minimize their product’s dangers while emphasizing its effectiveness and wide acceptance.  This practice has resulted in drug manufacturer liability despite a printed warning.

White Laboratories utilized detail men to distribute a brochure to doctors about dienestrol’s indicated use. The brochure was a promotional effort which White Laboratories knew would be relied upon by doctors. The distribution was a form of salesmanship,  and the dienestrol brochure was the product information provided to doctors. This brochure only contained references to studies and a personal communication which reported estrogen to be an effective method of preventing accidents of pregnancy. Although the medical director and management of White Laboratories were aware of studies which indicated that DES had no value in preventing threatened abortion and studies which demonstrated that estrogens caused cancer and fetal abnormalities, these studies were not included in the dienestrol brochure. Although a statement that use of estrogen was considered investigational was included, any reference to risk was omitted.

HISTORY OF THE MEDICAL CONTROVERSY SURROUNDING DES

DES As a Carcinogen

At trial, plaintiff presented “extensive evidence describing studies prior to 1952” which suggested a causal relationship between synthetic estrogen and cancer in animals. Dr. Michael Shimkin, “one of the earliest and still among the most eminent researchers in the field,” testified that by 1940 the scientific community viewed the eventual demonstration of synthetic estrogen’s carcinogenic effects in humans to be a “lead pipe cinch.” In his view, any drug manufacturer should have been aware of this. Dr. Shimkin also described in extensive detail several pre-1952 studies which demonstrated that the introduction of estrogen into the system of a pregnant animal could affect her offspring, and that the introduction of other carcinogens into the system of a pregnant animal could cause cancer in the offspring. Dr. Shimkin concluded that, in 1952, any drug firm planning to market a drug like dienestrol for use in pregnant women should have viewed animal testing for intergenerational effects as essential. The drug company also should have warned of the risk of cancer in 1952.

Dr. Neary, White Laboratories’ medical director at the time dienestrol was marketed, testified that it was “standard practice” when dealing with a new drug to consider publications on both clinical use of the drug and animal experimentation with the drug.110 At the time dienestrol was marketed, Dr. Neary was familiar with a 1940 study which revealed abnormalities in male and female offspring of female rats injected with estrogen. He acknowledged that estrogens had been shown to induce tumor formation in animals. He also knew, at that time, of a warning issued by the editors of the Canadian Medical Journal that since synthetic estrogens were chemically related to some carcinogenic substances, notably coal tar, a warning was justified on purely theoretical grounds.

In 1948, a doctor who was later employed by White Laboratories had written that endometrial hyperplasia in humans could be considered a precancerous lesion. Dr. Neary acknowledged that endometrial hyperplasia was an expected pharmacological effect of estrogen use. He also admitted that he knew the tissue of the developing fetus was more susceptible than adult tissue to carcinogenic transformation. Yet, prior to marketing dienestrol for use in pregnant women, Dr. Neary did not commission any research to determine whether estrogens caused cancer in the mother or the child.

At trial, and on appeal, White Laboratories disputed the importance and applicability of animal studies to the human experience and argued that these studies could not provide notice of the need for human testing. Dr. Shimkin, however, was “unequivocal” in his assertions that the animal studies were known at that time to indicate potential danger to humans. Although Dr. Neary recognized the relevance of animal research to certain aspects of new drug development, he believed that the application of animal studies to human beings was controversial. 121 Consequently, prior to marketing dienestrol for use in pregnant women, the management of White Laboratories consciously decided not to do any testing to determine whether dienestrol was safe for use in human beings.

The district court’s ruling in Needham which upheld the evidentiary use of animal studies to show knowledge of a risk of injury in humans was correct. In other drug cases, courts have considered the results of animal tests which revealed injuries similar to but not the same as the injuries sustained by a plaintiff to be evidence of knowledge or notice of the risk of injury which required a warning about that risk. A manufacturer is deemed to constructively know the results which testing and inspection of its product could have revealed.  Courts accordingly have based liability on inadequate testing, together with failure to warn.  It hardly seems fair to the consuming public to allow a drug manufacturer which has failed to test its product to escape liability for failure to warn about dangers which could have been discovered by adequate testing. “The claim that a hazard was not foreseen is not available” to a drug manufacturer who does not “use foresight appropriate to his enterprise.”

Risks versus Benefits: Dienestrol as an Ineffective Therapeutic Agent
Standards for Testing Drugs

Dr. Shimkin testified that recognized testing methods existed in 1948 to determine drug safety and efficacy.  He identified the principle method of scientific testing as the controlled experiment, which scientists viewed as an important means to eliminate bias. Controlled experiments were considered essential to evaluate the ability of estrogen to prevent threatened abortion because pregnancy is affected by many factors, such as diet and psychological state. Consequently, it would be imperative to design a study which would control for these factors by treating all research subjects in the same manner. Use of a placebo in the nonmedicated group compared to use of the experimental drug in the medicated group is an example of such a control. The paradigm of controlled experiments, and the most favored testing method in 1952, is the double blind study in which neither the researcher nor the research subject knows whether the drug given is a placebo or a real drug-in all respects both groups being compared are treated and evaluated in the same manner.

Claims of Effectiveness from Poorly Controlled Studies

Articles published by Drs. Olive and George Smith in the late 1940s were primarily responsible for the belief that DES would reduce the incidence of threatened abortion. The Smiths theorized that a lack of the hormone progesterone caused early termination of pregnancy, and that DES could stimulate production of progesterone, thereby preventing abortion. Other scientists severely criticized both the theory that reduced progesterone caused abortion, and the method that the Smiths used to measure the efficacy of DES and its alleged progesterone stimulating qualities. As early as 1949, the Smiths were severely criticized for lack of adequate controls, and controlled studies performed in the early 1950s refuted the Smiths’ claims of DES effectiveness in preventing threatened abortion.

White Laboratories’ Decision to Market Dienestrol to Treat Threatened Abortion

The medical director of White Laboratories, Dr. Neary, relied on the Smiths’ articles to establish DES effectiveness in the treatment of threatened abortion.  Before submitting the supplemental NDA to the FDA, Dr. Neary reviewed the published material concerning the use of estrogen in experimental animals and humans. He knew that the usefulness of DES in treating threatened abortion was controversial, and he informed the management of White Laboratories of this controversy.  The supplemental NDA, however, did not list any publication which indicated that the use of DES was controversial.

In a letter to White Laboratories, the American Medical Association questioned the effectiveness of dienestrol and criticized the NDA data as “completely uncontrolled,” resulting in “obscure” criteria for the use of estrogen in treating threatened abortion. Nevertheless, Dr. Neary failed to conduct further tests to determine the effectiveness of dienestrol. He did inform management of two studies indicating that DES was of no value and a “dismal failure” in preventing threatened abortion, and also told management that pregnant animals treated with estrogen had aborted. These facts, however, were not included in the supplemental NDA or the product information brochure, although White Laboratories and Dr. Neary knew that doctors would rely on the brochure to determine dosage and instructions for use.

Dr. Albert Schmitt, an obstetrician who has done extensive work with DES-related problems, described these reports as “inadequate testing,” and also characterized as irresponsible the Smiths’ suggested hundredfold increase in dosage for pregnant women. Both Dr. Schmitt and Dr. Shimkin criticized White Laboratories’ reliance on the Smiths’ articles to determine dienestrol’s safety and efficacy in the treatment of threatened abortion: a review of articles which favored estrogen use in pregnant women and which were of questionable authority because of poor testing methodology was unacceptable premarketing practice. In Dr. Shimkin’s view, more premarket testing of dienestrol was required because estrogens were well known to be carcinogenic.

RELEVANCE OF DRUG EFFICACY EVIDENCE IN STRICT LIABILITY ACTIONS

The District Court’s Ruling in Needham
Comment k

Before determining when the comment k exception to strict liability applies, it is necessary to examine the products to which it applies. By its terms, comment k covers “unavoidably unsafe products;” those products which, “in the present state of human knowledge,” are incapable of being made safe for their ordinary and intended use. Unavoidably unsafe products are especially common in the field of drugs.

Comment k separates drugs into three categories.

  1. An example of the first category is the rabies vaccine. Because it prevents death, marketing and use of the vaccine are “fullyustified” despite the high degree of risk which the vaccine itself presents.
  2. In the second category are drugs which cannot legally be sold except to a physician or under prescription of a physician.
  3. The third category consists of new or experimental drugs in which, because of “insufficient time and opportunity for medical experience,” there can be no assurance of safety.

The seller of these three types of products is not to be held strictly liable in tort simply because the seller has undertaken to supply the public with an apparently useful and desirable product, as long as the product is accompanied by proper directions and warnings and is properly prepared.

Comment k, accordingly, has been referred to as an “exception” to strict liability which applies to the sellers of “established” but unavoidably unsafe, and new or experimental drugs. The obvious intent of comment k is to preclude drugs and other inherently dangerous products from being characterized as defective merely because of their inherently dangerous features. Consequently, when a plaintiff sues a drug manufacturer for strict liability in tort for failure to warn of a risk of injury from a drug, the courts and commentators assume that a drug is an unavoidably unsafe product which must be analyzed according to the provisions of comment k. This assumption accurately perceives that all drugs involve some risk of danger, and hence are unavoidably unsafe.

The district court in Needham, therefore, was correct in assuming that dienestrol was an unavoidably unsafe product which should be analyzed within the comment k framework. White Laboratories’ defense throughout the trial was that dienestrol was a new or investigational drug, the dangers of which were unknown in 1952 when plaintiff was exposed to it. If this were true, and if dienestrol were an apparently useful and desirable drug, White Laboratories could escape liability for failure to warn of the danger since it did warn that dienestrol was an investigational drug. If the defendant did know of the risk of harm, the jury could determine that this warning was inadequate.

The district court also properly construed comment k as interpreted by the Illinois Supreme Court in Woodill v. Parke Davis. In that case the court held that when a plaintiff sues a drug manufacturer based on strict liability in tort for failure to warn of a danger the plaintiff must, in accordance with comments j  and k, plead and prove that the manufacturer knew or should have known of the risk inherent in the drug. Thus, a drug manufacturer in Illinois cannot be held strictly liable for failure to warn of a risk unless liability can also be based on negligent failure to warn, that is, unless the evidence would support a finding that the seller should have foreseen the danger.

The Woodill decision, however, did not involve a challenge to the drug’s usefulness and the manufacturer’s decision to market it was tacitly assumed to be reasonable despite the attendant risk. Consequently, the comment k knowledge standard was properly applied. Comment k does not, however, limit drug manufacturer liability under all conditions. The protection from strict liability afforded by comment k might be lost if a drug that offered no substantial benefit caused an injury, even if the injury were not foreseeable.  Such a drug would be considered unreasonably dangerous as marketed or unreasonably dangerous per se.

To determine whether a drug provides a substantial benefit, and therefore comes within the comment k exception to strict liability, the drug’s benefits or apparent usefulness and desirability must be weighed against its risks. If the “risk/benefit” analysis under comment k renders a product unreasonably dangerous, sale of the drug results in strict liability regardless of the manufacturer’s ignorance of the dangers.  Where a seller has marketed an apparently useless drug, the reason for the comment k exception-to give sellers of drugs an incentive to continue producing useful and beneficial drugs-is not present. The seller of such a product should not be entitled to greater protection than the seller of a product which has a manufacturing defect. Society’s interests are not served if an unavoidably unsafe product has a high degree of risk and an occasional or nonexistent benefit, yet enjoys insulation from strict liability in tort despite its predominantly detrimental effects. This is the reason the comment k exception to strict liability requires a predominant character of usefulness-and beneficiality.

Strict liability in tort is particularly appropriate where this beneficial character is lacking in a drug. The drug industry is highly competitive; new drugs must be produced to ensure a drug company’s continued existence.  The potential profits from a commercially successful new drug are enormous. In an economic sense then, strict liability is justified by the manufacturer’s superior ability to absorb the costs of minimizing risks and ensuring drug efficacy. Although production of safe and useful drugs can only be accomplished through more extensive testing, which would increase the price of drugs, consumers directly benefit from the availability of a drug whose benefits far outweigh its risks, and from escaping exposure to drugs which are ineffective and dangerous. The possibility of strict liability may provide drug manufacturers with an incentive to market drugs which are effective and beneficial as well as profitable. It may also encourage drug companies to divert a portion of their huge advertising and promotion budgets to researching and testing of their products.

It is readily apparent that the risk/benefit analysis required under comment k to determine whether a product’s marketing was justified, necessitates evidence of the product’s efficacy or lack of efficacy. When the efficacy of a drug is manifestly outweighed by its risks, or is nonexistent, proof of fault-knowledge of a risk of injury and failure to warn-is unnecessary to a finding of liability.

In Needham, the district court ruled that evidence of dienestrol’s lack of efficacy was relevant. A pretrial ruling noted that drugs are commonly considered unavoidably unsafe products under comment k. Citing the language of comment k, the district court noted that such products are not unreasonably dangerous, and therefore do not come within the purview of strict liability, if they are properly prepared and accompanied by directions and warnings:

The seller of unavoidably unsafe products, again with the qualification that they are properly prepared and marketed and a proper warning is given, where the situation calls for it, is not to be held to strict liability for the unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

The district court interpreted this language to mean conversely that strict liability may be imposed upon a manufacturer, irrespective of warnings, if the product at the time of marketing was not apparently useful. Accordingly, evidence of efficacy was relevant to determine whether or not dienestrol was apparently useful when marketed. The precise question to be addressed, in the court’s view, was whether there were sufficient technological experience and testing standards in 1952 to justify the marketing and use of dienestrol. The issue to be resolved was not whether dienestrol was actually useful, but whether dienestrol was apparently useful.

In later opinions, the district court affirmed its ruling that evidence of dienestrol’s ineffectiveness was relevant to foreclose reliance on the lack of knowledge defense provided by comment k. If there was no reason to believe in 1952 that dienestrol was useful in preventing threatened or habitual abortion, the court reasoned, the marketing of dienestrol was not justified. Consequently, the comment k curtailment of the normal strict liability standard could not be applied. The absence of any apparent utility would render the drug unreasonably dangerous, and irrespective of its knowledge of dienestrol’s danger, White Laboratories could be held strictly liable in tort. Evidence of efficacy was deemed crucial to the case and its omission, in the court’s view, could require reversal.

Strict Liability Based on a Drug Defect

To recover under section 402A of the Restatement (Second) of Torts, a plaintiff must prove that the proximate cause of his or her injury was a defect in the product which rendered the product unreasonably dangerous. The rationale for imposing strict liability is set forth in comment c:

The seller, by marketing his product for use and consumption, has undertaken and assumed a special responsibility toward any member of the consuming public who may be injured by it; that the public has the right to and does expect, in the case of products which it needs and for which it is forced to rely upon the seller, that reputable sellers will stand behind their goods.

Public policy demands that the burden of accidental injuries caused by products intended for consumption be placed upon those who market them, and be treated as a cost of production against which liability insurance can be obtained.

Certainly, drugs are necessary products for which the consumer must rely upon the seller who markets them for consumption. Thus it would seem that a drug manufacturer has a special responsibility under section 402A to a member of the consuming public who is injured by its drug. The design and manufacturing process must yield a product which reflects the proper balance of efficiency and safety. The Restatement test to determine whether particular risks posed by a product make it defective and unreasonably dangerous is whether the article is more dangerous than would be contemplated by the reasonably informed consumer.  Under this test, drugs which are ineffective and unsafe would be defective and unreasonably dangerous.

Design Defects

The defect asserted by the plaintiff in Needham was that dienestrol was ineffective and unreasonably dangerous as marketed for its intended use. This description comes within the Restatement’s consumer-expectation definition of a defective and unreasonably dangerous product. The difficulty with using the Restatement test in a prescription drug case is that the consumer does not purchase the drug directly from the seller, but through a learned intermediary, the prescribing physician. Substituting the word “physician” for “consumer” would resolve this difficulty. If the risks of a drug manifestly outweigh its benefits, the drug is dangerous beyond the extent contemplated by either the consumer or the prescribing physician.

The drug was in the condition the manufacturer intended, hence the injury resulting from its use can be analogized to an injury caused by a defect in design. In a design defect case, the product conforms to the manufacturer’s plan or design, but certain intended characteristics render the product not reasonably safe. In the case of drugs, something in the formula makes the product dangerous.  In a strict liability sense, the product defect in drugs is, in most instances, due to a laggard approach to research design formulation. Design defect claims protect the consumer’s interest in avoiding exposure to a product posing risks which so far outweigh its benefits that it should not continue to be marketed.

Although the definition of defect in a drug may differ from the definition of defect in a machine, the theory of strict liability is the same in both cases. 190 As Justice Traynor cogently noted:

If we scrutinize deviations from a norm of safety as a basis for imposing liability, should we not scrutinize all the more the product whose norm is danger? Such scrutiny is especially sensible for drugs for which a reasonably safe substitute exists. Thalidomide sleeping pills afford a recent dramatic example of such a dangerous product. Other drugs, which must be used despite the danger, perhaps should be treated differently.

Despite a lack of negligence, public policy demands that responsibility be fixed wherever it will most effectively reduce the hazards to life and health inherent in defective drug products. The responsibility is appropriately fixed on the drug manufacturer because “the manufacturer can anticipate some hazards and guard against the occurrence of others as the public cannot. In addition to being in a superior position to reduce the injury, the manufacturer is in the best position to spread the cost of the injury; the consumer can least afford the devastating impact of disability.

Where a product is inherently unsafe, strict liability requires that the marketer face the test of usefulness and reasonable purpose for the product in the marketplace. ‘To the degree a product is unsafe, a similar degree of justification will have to be found for offering it for use or consumption.” Marketing a drug which lacks therapeutic potential is unreasonable when that drug also presents a risk of harm. ‘The less effective a drug is, the more its risks become unreasonable.” This formulation is reflected in the design defect theory articulated by the California courts. Other courts have held that proof of the manufacturer’s fault is unnecessary where the efficacy of the drug is manifestly outweighed by its risks’ -the drug is defective and unreasonably dangerous in a strict liability sense.

Illinois courts have defined defective products to be those products which are dangerous because they fail to perform in the manner reasonably to be expected in light of their nature and intended function. Proof that, in the absence of abnormal use or reasonable secondary causes, the product failed so to perform establishes a prima facie case that the product was defective. Whether a product has failed to perform in the manner that would reasonably have been expected, and whether this failure caused plaintiff’s injury, are questions for the jury. Although the Illinois cases that produced this definition involved hammers, ladders, and brakes, the strict liability principles articulated in these design defect cases apply as well to defects in the design of drugs. The policy reasons for imposing strict liability are the same in each instance.

The strict liability rationale was set forth in Suvada v. White Motor Co. before Illinois adopted the Restatement view of strict liability. In Suvada the supreme court discussed the rationale in terms of the consumption of food, but the reasoning is especially applicable to drugs. First, the public interest in human life and health demands all the protection the law can give against unwholesome food. This policy applies equally to unwholesome drugs–drugs which are of questionable efficacy and a high risk of harm. Second, the manufacturer solicits and invites the use of its product by packaging, advertising, or otherwise representing to the public that it is safe and suitable for use. With respect to drugs, the inducement is aimed at the prescribing physician, who then orders the drug for the consumer.

Third, the losses caused by unwholesome food should be borne by those who have created the risk and reaped the profit by placing the product in the stream of commerce. In the case of drugs, the manufacturer’s high profits and few losses render this reason particularly forceful, especially since the profits are justified by asserting that a risk exists in developing new drugs. Moreover, where a drug manufacturer has placed a drug on the market which has been inadequately tested for efficacy and safety, the manufacturer has certainly created the risk. Consequently, the manufacturer should bear the losses caused by the drug. To quote Suvada:

It seems obvious that public interest in human life and health, the invitations and solicitations to the doctors to prescribe the product for a consumer] and the justice of imposing the loss on the one creating the risk and reaping the profit are present and as compelling in cases involving motor vehicles, food, and other products, where the defective condition makes them unreasonably dangerous to the user, as they are in drug cases.

The strict liability principles were later affirmed by the Illinois Supreme Court in Liberty Mutual Insurance Co. v. Williams Machine and Tool Co . The court asserted that the major purpose of strict liability is to place the loss caused by defective products on those who create the risk and reap the profit from placing defective products on the market. This rationale should apply to drug actions which assert strict liability based on a defect.

Efficacy Evidence

It is readily apparent that to determine whether a product is defective, evidence of efficacy or lack of efficacy together with evidence of danger is necessary. For example, in one product defect case, evidence of both brake failure and brake effectiveness was introduced to determine whether the product failed to perform in the manner reasonably to be expected in light of its nature and intended function. Similarly, evidence of efficacy must be presented in addition to evidence of dangers in a drug defect case to determine whether a drug performed in a manner reasonably to be expected. Accordingly, the district court correctly ruled that evidence of efficacy was relevant to plaintiff’s claim for strict liability based on a defect. The plaintiff claimed that the drug was defective because it was not safe for its intended use and was ineffective. Consequently, dienestrol failed to perform in the manner reasonably to be expected in light of its nature and intended function.

The district court relied on the Illinois Supreme Court’s refusal in Woodill v. Parke Davis & Co. to impose a requirement that defendant have knowledge of the potential danger in design defect cases. The district court also referred to the Woodill court’s reliance on the comment k balancing of benefits against risks and, citing Cunningham v. MacNeal Memorial Hospital, noted that if the product was not “one of those useful but unavoidably dangerous” products described in comment k, then liability could be imposed “even in the absence of the knowledge of the dangers involved.” The district court concluded that the principles of strict liability based on a defect remained substantively unchanged by the Woodill decision.  Unfortunately, the court expressed no opinion on whether the evidence would have supported a verdict for plaintiff on the defect theory. The district court merely reaffirmed its ruling that efficacy evidence was admissible under this theory.

Authority for the District Court’s Ruling

Cunningham v. MacNeal Memorial Hospital involved a transfusion of blood contaminated by hepatitis virus. The Illinois Supreme Court held the hospital supplier of the blood strictly liable and refused to apply the comment k exception for unavoidably unsafe products. The court held that blood containing hepatitis virus is impure and therefore in an unreasonably dangerous defective condition. Comment k was construed to apply only to products which are not impure and which, even if properly prepared, involve substantial inherent risk of injury to the user.

Later, in Woodill v. Parke Davis & CO., the Illinois Supreme Court referred to the distinction between strict liability based on a defect in a product “such as was involved in [Cunningham]” and an unavoidably unsafe product such as the one involved in Woodill.  Woodill made it clear that the knowledge of risk requirement was not a “weakening” of the Cunningham rule that proof of a defect suffices for strict liability ; comment k applies only to unavoidably unsafe products. The court also refused to extend the knowledge requirement to design defect cases.

The district court interpreted the Woodill court’s reaffirmation of Cunningham as authority for premising strict liability for a drug injury on a defect in the drug. The defect in dienestrol was not an impurity, as in Cunningham, but rather a design defect. The court therefore inferred that Cunningham’s applicability to strict liability actions for other types of defects such as design defects should be broadly construed. There is language in Woodil1 and in another drug case, Lawson v. G.D. Searle, which supports this inference. Interpreting this language together with the strict liability principles articulated in design defect cases involving products other than drugs, it is reasonable to conclude that the Illinois courts would uphold a claim based on a design defect in a drug such as that alleged in Needham. Consequently, the admission of efficacy evidence on this basis was correct.

Reversal by the Court of Appeals
Comment k Risk/Benefit Analysis

On appeal, the Seventh Circuit criticized the district court’s ruling on the admissibility of efficacy evidence as an erroneous interpretation of Illinois law. In the Seventh Circuit’s view, only three possible kinds of defective products could result in strict liability in Illinois, and none of these include the design defect:

  1. a product contaminated by an impurity;228
  2. a product unaccompanied by a warning of the product’s dangerous propensities, also called a comment j case;229
  3. and a product which is accompanied by a warning but in which the risk of danger outweighs the benefit of use, also described as a comment k case.

The court further explained that a comment k case exists only where the manufacturer warns of the danger, and yet the product remains dangerous even if the warning is followed. Evidence of efficacy is relevant, in the Seventh Circuit’s opinion, only to this third kind of defect, a comment k case. Only here is it necessary to weigh the drug’s apparent usefulness against its risk to determine whether the drug is unreasonably dangerous. The court found it necessary to adopt another jurisdiction’s analysis of comment k since the Illinois Supreme Court had not “yet decided a comment k case” but had only “commented” on the applicability of comment k to products which are not impure and involve substantial inherent risk of injury even if properly prepared.

Citing Woodill, the Seventh Circuit determined that comment j, rather than comment k, governed the Needham action because no warning accompanied dienestrol. Efficacy evidence was therfore held to be irrelevant to the “dispositive issue,” in the case: Wihether White should be held liable for its failure to warn of the risk of cancer to offspring of pregnant women who ingested Dienestrol.

The Court of Appeals reasoning is faulty for several reasons. First, it ignores the existence of liability for a design defect in Illinois. Second, the court incorrectly interpreted Illinois case law to distinguish between comment k and comment j cases. Third, the court erroneously asserted that the Illinois Supreme Court had not yet decided a comment k case. Fourth, the court ignored the new-drug provisions of comment k which apply to dienestrol.

Comment k and Comment j

Illinois drug cases based on strict liability for failure to warn do not support the Seventh Circuit’s distinction between comments j and k. The Illinois courts have not dichotomized the comments to apply comment j only in cases where a warning of a risk is lacking, and comment k only in cases where a warning is given. Rather, the Illinois courts have construed comments j and k together to determine that a manufacturer of a beneficial drug must have actual or constructive knowledge of a risk of danger before it can be held strictly liable for failure to warn of that risk.

Furthermore, it is simply incorrect to say that Illinois has not yet decided a comment k case. Several Illinois drug cases based on strict liability for failure to warn have expressly relied on comment k to resolve the issues. In Woodill v. Parke Davis & Co , the Illinois Supreme Court placed great reliance on comment k for resolution of the strict liability failure to warn issue. Despite the absence of a warning accompanying the drug, the court, adopting comment k language, described the product as an unavoidably unsafe product.  Other drug cases reveal a tacit assumption by Illinois courts that prescription drugs, by their nature, are unavoidably unsafe products which must be analyzed according to the provisions of comment k. A discussion of Woodill will exemplify these issues.

In Woodill, the plaintiff sued the drug manufacturer, alleging strict liability for failure to warn physicians and consumers of the danger in using the drug pitocin to induce labor in pregnant women when the fetus is in a certain position. As in Needham, there was no warning given about this danger. The court, nevertheless, characterized pitocin as an unavoidably unsafe product.  In so doing, it did not distinguish between comnients j and k, but did distinguish between the nonapplicability of comment k in strict liability defective product cases. Citing Cunningham, the Woodill court stated:

Later in Cunningham we distinguished between strict liability based on a defect in a product, such as was involved therein, and where, as here, warning may be required because a product is unavoidably unsafe. We referred to the “exception” created by comment k to Section 402A of the Restatement (Second) of Torts: k. Unavoidably Unsafe Products.

There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified …. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous …. We believe it clear that the exception set forth in the quoted comment relates only to products which are not impure and which, even if properly prepared, inherently involve substantial risk of injury to the user.

The Woodill court went on to hold:

Therefore, the pleading requirement that a manufacturer know or should know of the dangerous propensity of the product is limited to complaints which allege a breach of the duty to warn adequately. Whether it is necessary to allege knowledge where liability is predicated on the defective design of the product is not before us.

The Woodill discussion of the knowledge requirement is replete with references to the language of comment k. For example, to describe the pleading and proof requirements of a strict liability failure to warn action, the court stated that “the inquiry becomes whether the manufacturer, because of the ‘present state of human knowledge, . . . knew or should have known of the danger presented by the use or consumption of the product. Again using the language of comment k, the court expressed one of the reasons for imposing the knowledge limitation: If a manufacturer is held liable for failure to warn of a danger which it would be impossible to know about “based on the present state of human knowledge,” then the manufacturer would become “an insurer of its product. Finally, in language which parallels the rationale of comment k, the court set forth the policy reasons for imposition of a knowledge requirement in strict liability failure to warn cases:

This court is acutely aware of the social desirability of encouraging the research and development of beneficial drugs. We are equally aware that risks, often grave, may accompany the introduction of these drugs into the market place. We simply think, however, in accordance with comments j and k of Section 402A… that where liability is framed by the manufacturer’s duty to warn adequately of dangers which may arise from the use of a drug that liability should be based on there being some manner in which to know of the danger.

The Illinois appellate court also has relied “particularly” on comment k to conclude that “without doubt, Section 402A… comment k, discloses that a prescription drug may be deemed unreasonably dangerous if it is manufactured and distributed without adequate warnings … .- Implicit in this formulation is the assumption that comment k applies to all prescription drugs because these products are inherently dangerous by nature and therefore unavoidably unsafe products. The presence or absence of warnings determines whether the useful product is unreasonably dangerous, not whether it is unavoidably unsafe. Before a warning is required under Woodill, however, the manufacturer of a beneficial drug must have known or have been able to discover the risk of danger. If knowledge of a risk exists and a warning is provided, the product is not unreasonably dangerous; if such knowledge exists but a warning is not given, the product is unreasonably dangerous.

Woodill’s reliance on comment k belies the notion that it can be characterized as a comment j, as opposed to a comment k case. Woodill also demonstrates that a warning is not a prerequisite to comment k applicability. The Seventh Circuit’s conclusions concerning comment k directly oppose those of the Illinois Supreme Court. Although the Seventh Circuit recognized its responsibility to apply the substantive law of Illinois, it evaded this obligation.

To justify the application of another jurisdiction’s substantive law, the Seventh Circuit simply asserted that the Illinois Supreme Court had not decided a comment k case. Perhaps what the court meant was that the fllinois courts had not been confronted with a case like Needham, that is, a strict liability failure to warn action in which the plaintiff claimed that the drug involved was not beneficial-not an apparently useful product-in addition to asserting that it posed a risk of harm about which there was no warning. Consequently, Illinois courts have not been asked to balance a drug’s risk of harm against its benefits to determine whether the manufacturer’s decision to market the drug was justified. In the Illinois drug cases decided thus far, the drug has been presumed to be beneficial. Thus the comment k rationale for imposing a knowledge requirement applies to those cases, and the courts accordingly have imposed liability in these circumstances in accordance with the comment k exception to strict liability: The manufacturer of a beneficial drug is liable for failure to warn only of known dangers.

It seems likely, however, that if the Illinois Supreme Court were faced with a challenge to a drug’s benefits, it would resolve the issue using efficacy evidence, in the same manner as other courts have resolved it.  If, as in Needham, the drug’s risks manifestly outweigh its benefits, then under the comment k analysis, the knowledge requirement, which protects or excepts the manufacturer from strict liability, would not be applied. In relaxing the strict liability rule in failure to warn cases, the Woodill court clearly indicated that the underlying policy of this rule was to favor the development of beneficial drugs. Conversely, then, if a drug’s benefits were manifestly outweighed by its risk, that is, if the drug were ineffective and caused serious harm, the policy favoring the development of beneficial drugs would not be furthered by allowing comment k protection to the manufaturer. The manufacturer would be held strictly liable for failure to warn, irrespective of its knowledge of dangers.

The Seventh Circuit’s Comment k Analysis

Instead of applying Illinois law, the Seventh Circuit adopted the comment k analysis articulated in Reyes v. Wyeth Laboratories, which it mistakenly interpreted as a case in which a warning of risks is given and yet the product remains dangerous even if the warning is followed. The manufacturer is exempt from liability only if the product’s benefits outweigh its risks. In Reyes, however, no warning was provided, although the risk of danger was known. Nevertheless, the court found that the vaccine was an unavoidably unsafe product and thus that comment k applied. Because no warning as to the vaccine’s dangers was provided, the Reyes court held Wyeth Laboratories strictly liable under a comment k analysis. The Seventh Circuit was therefore mistaken in indicating that a warning must have been given for comment k to be applicable.

In analyzing the issue within the comment k framework, the Reyes court first determined whether the vaccine was unreasonably dangerous per se by determining whether marketing it was justified despite the danger involved in its use. After concluding that marketing the vaccine was justified, the court went on to decide whether the drug was unreasonably dangerous as marketed, which in a drug case translates to “a duty to provide proper warnings.

According to the Reyes comment k analysis, the first, rather than last, step is to determine whether the drug’s apparent usefulness outweighs its known risk. If it does, then the marketing of the drug is justified; if it does not, the drug is unreasonably dangerous per se. At this juncture, the question of warnings, whether given or not, need not be addressed. To determine whether a product is unreasonably dangerous per se, it is apparent that evidence of efficacy or lack of efficacy must be adduced. Without this evidence, it is impossible to determine whether the drug’s apparent usefulness outweighs its known risks. Thus, under Reyes, the evidence of dienestrol’s ineffectiveness clearly was not irrelevant or prejudicial. Rather, this evidence was a crucial aspect of the case. The Reyes analysis supports the district court’s ruling that evidence of dienestrol’s efficacy or lack of efficacy is relevant to the Needham action.

If the Seventh Circuit had correctly applied the Reyes court’s analysis to the facts adduced during the Needham trial, it would be hard pressed to escape the conclusion that dienestrol was unreasonably dangerous per se. As of 1952, the efficacy of dienestrol in preventing threatened abortion was admittedly “controversial” according to White Laboratories’ medical director, and White Laboratories was aware that other scientists had concluded that dienestrol was a dismal failure. Thus, White Laboratories knew or should have known that dienestrol was not apparently useful. The additional knowledge that DES-related estrogens such as dienestrol caused tumor formation and abnormal anatomical changes in the offspring of pregnant animals, as well as cancer, leads to the conclusion that the known risks far outweighed its benefits. Even if the Seventh Circuit viewed animal studies as inconclusive proof of actual danger to humans, the jury was entitled to believe the testimony of plaintiff’s experts that animal studies were viewed as reliable indicators of risks to humans. Although the Needham district court did not make a finding as to the sufficiency of the efficacy evidence, it did find that the evidence supported a jury verdict for plaintiff on the basis of White Laboratories’ knowledge of the risk of cancer to female offspring exposed in utero to dienestrol. The Seventh Circuit did not refute this finding. Under the Reyes analysis, the evidence presented at the Needham trial established that White Laboratories’ decision to market dienestrol was not justified. Given the gravity of the potential harm, the controversial and questionable efficacy of dienestrol could not possibly be found to outweigh its known risk. Dienestrol is unreasonably dangerous per se within the meaning of Reyes.

Another Seventh Circuit View of Comment k: Singer v. Sterling Drug

The requirement that comment k be applied only when the manufacturer has warned of the risk and the product remains dangerous even if the warning is followed is supported by the Seventh Circuit’s earlier decision in Singer v. Sterling Drug, which established two classifications of drugs which fall within the comment k exception to strict liability. First, comment k applies to drugs in which there is a known but apparently reasonable risk of injury and the user has been warned of the risk. An example of this drug is the Pastuer vaccine for rabies. The second class to which comment k applies is the new or experimental drug for which there is no knowledge of risk and the user has been warned that the drug is new or experimental. An example of this type of drug is dienestrol.

The Seventh Circuit’s decision in Needham addresses only the first category of comment k drugs; the second category is notably missing from the court’s discussion of comment k. This omission is significant because White Laboratories relied on the second category as a defense. Throughout the trial, White Laboratories maintained that knowledge of dienestrol’s risks had not and could not be discovered in 1952, and that White Laboratories had warned that the use of dienestrol in the treatment of threatened abortion was investigational. The Seventh Circuit simply ignored this evidence and did not address the second comment k category formulated in Singer. In categorizing comment k drugs in two classes, Singer itself made a notable omission. The text of comment k refers to prescription drugs, which Singer ignored, apparently because the court viewed with disfavor the applicability of the comment k knowledge requirement in all prescription drug cases based on strict liability for failure to warn. The Woodill court imposes this requirement on all failure to warn cases which involve beneficial drugs. Thus, Singer rejects the underlying premise of Woodill, and therefore is questionable authority for Illinois strict liability law.

Strict Liability Based on a Defect

In Needham, the plaintiff’s second theory of strict liability was that dienestrol was defective because it was useless and unreasonably dangerous. The Seventh Circuit held that the district court’s alternative ruling, which allowed evidence of lack of efficacy to prove dienestrol defective, was not supported by Cunningham v. MacNeal Memorial Hospital. The district court relied on Woodill to support its view that the knowledge of risk requirement applied in strict liability failure to warn cases, and that the usual rule in other strict liability cases, that proof of a defect suffices, remained undisturbed. Cunningham was cited as authority for the usual strict liability rule that proof of a defect is sufficient. The district court’s interpretation was correct. The Woodill court clearly stated that it was not imposing a knowledge requirement in either a product defect or design defect case. In reaching this decision, the Woodill court cited the Cunningham distinction between strict liability based on a defect and strict liability based on the manufacturer’s failure to warn, and noted that comment k only applied to the failure to warn action.

Despite the Woodill references to defect cases such as Cunningham, and to design defect cases, the Seventh Circuit essentially held that an impurity such as that in Cunningham was the only kind of product defect on which strict liability could be based. Since the plaintiff in Needham did not claim that dienestrol contained any impurity as did the plaintiff in Cunningham, the Cunningham case did not “govern.” The Seventh Circuit interpreted the district court’s citation to Cunningham as a ruling that an ineffective product is a defective product. Citing section 402A, the Seventh Circuit held that ineffectiveness of a product is not actionable under strict liability theory.

The district court, however, had not ruled that plaintiff’s case was governed by Cunningham. Rather, the district court extrapolated from Cunningham the principle that proof of a defect, without proof of knowledge of the defect, is sufficient to establish strict liability based on that defect. Likewise, the district court did not hold that an ineffective product is necessarily a defective product. The plaintiff’s alternate theory of strict liability was premised on the claim that dienestrol was defective because it was ineffective and unreasonably dangerous. If the drug was both ineffective and the cause of plaintiff’s cancer, as the jury was instructed, then the drug was defective. The theory is supported by Illinois case law. To distinguish between an ineffective drug and an ineffective brake, both of which subsequently cause injury, is not legally justified for purposes of strict liability.

The real difference between these products is in their nature; the brake is only dangerous if it is ineffective, while the drug is always potentially dangerous. A drug is ingested despite its danger because it is an effective therapeutic agent against some other harm. Such a drug is not unreasonably dangerous. If, however, the drug does not prevent some other harm, that is, if it is useless, then the danger it poses is unreasonable. In the first situation there is reason for exposing oneself to potential danger-the drug is taken to avoid some other harm. If the drug does not prevent this other harm, then it follows that it is not reasonable to expose oneself to the drug’s potential dangers. Such a drug is unreasonably dangerous.

These differences in the kinds of product defects are not of sufficient import to deny strict liability for drug defects. The response of the courts can be either to adhere rigidly to prior doctrines, denying recovery to those injured by such products, or to fashion remedies to meet these changes. From a strict liability policy standpoint, the manufacturer of drugs is better able to bear the cost of injuries resulting from defective products. The manufacturer is in the best position to test for and discover, as well as guard against, defects in its products. The threat of strict liability will provide an incentive to produce safer drugs. The drug-consuming public needs protection from defective drug products. The Seventh Circuit’s holding creates a blanket protection from strict liability for drug manufacturers who develop, promote, and profit from an ineffective and dangerous drug. This decision is contrary to Illinois strict liability consumer protection goals.

CONCLUSION

The protection afforded by comment k to drug manufacturers applies only if the drug’s benefits outweigh its risks. Where a plaintiff challenges the manufacturer’s decision to market the drug as unjustified by asserting that the drug is not beneficial, evidence of efficacy or inefficacy is relevant to decide the claim. If the decision to market the drug was not justified because its apparent usefulness was outweighed by its risks the manufacturer loses the protection of comment k and may be held strictly liable. Comment k protection was intended for manufacturers of beneficial drugs only.

On the other hand, if a drug had no apparent usefulness and it caused injury, the manufacturers may be held strictly liable for manufacturing a defective product in an unreasonably dangerous condition. The result under either theory, the loss of comment k protection, is the same, and evidence of efficacy or lack of efficacy is relevant to both theories. These theories are supported by Illinois case law and by decisions in other jurisdictions.

Moreover, the imposition of strict liability on the drug manufacturer who develops, promotes, and profits from an apparently useless and dangerous drug is a just result. It would be manifestly unfair to thrust upon the consumer the burden of paying for the treatment of injuries caused by such drugs. The high profits and few losses in the drug industry reveal that a drug company is in a better position than the injured consumer to absorb and spread the cost of compensating for drug injuries. It is time to make the justification for these high drug profits a reality; manufacturers who develop, for profit, apparently useless and dangerous drugs must also accept the risk in such developments. The district court’s ruling promotes this goal; the Seventh Circuit’s decision defeats it. The Needham reversal signified another victory for the drug companies, and yet another disaster for the consumer.

The Seventh Circuit’s opinion in effect allows drug companies to develop and sell useless drugs with no concern about whether or not these drugs are dangerous, since the manufacturers will not be strictly liable in tort for injuried caused by such drugs. And as long as neither the drug manufacturer nor anyone else tests for the drug’s dangers, the manufacturer will not be liable for failure to warn because it will not know of the danger until some time after the drug has been on the marketin the case of cancer, perhaps twenty years. During this time the manufacturer will have made an enormous profit. Of course, one would assume that after the manufacturer learns of injury caused by its product, it would warn consumers of the danger. But if the birth control pill experience is any indication, this assumption is grossly naive. The risk of cancer from estrogen consumption has only recently surfaced in the warnings accompanying the pill. Time may well prove that the development and promotion of estrogen products has been the greatest fraud ever perpetrated by drug companies. The courts should allow the victims of DES injuries to bring strict liability actions based either on a theory of defect or of failure to warn. Evidence of efficacy or usefulness should be deemed pivotal in such actions. Strict liability for drug injuries should exist in fact, not just in theory.

Mary E. Kelly, 1981.

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More DES DiEthylStilbestrol Resources

DES and The Identification Problem

DIETHYLSTILBESTROL (DES), a synthetic estrogen, was developed in 1937 and was widely prescribed in the 1940’s, 1950’s and 1960’s for pregnant women to prevent miscarriages. The drug has caused a number of maladies to daughters who were exposed in utero to the drug, the most serious of which is clear cell adenocarcinoma, a rare form of vaginal cancer. The Food and Drug Administration (FDA) withdrew its approval of DES as a miscarriage preventative in 1971, and since then the focus has shifted to products liability actions filed against the drug manufacturers. The plaintiffs have been largely unsuccessful in these actions, although some innovative judicial theories have recently been advanced in allowing recovery.

DES and The Identification Problem, AKRON LAW REVIEW, Vol. 16:3, Winter 1983.

This article will examine the history of this drug, how it was used and regulated as well as the subsequent legal turmoil and the proffered resolutions to the quandary. The impact of these theories and of proposals to “further strengthen product liability laws as a substitute for direct government intervention” will also be studied.

DISCOVERY OF DES

Diethylstilbestrol was first synthesized in 1937 by Dr. E. C. Dodds at Oxford and Middlesex Hospital in England. The abbreviation “DES” is used to designate diethylstilbestrol (which is also known as stilbestrol) and sometimes for the related synthetic estrogen, dienestrol, also discovered by Dr. Dodds.

Diethlystilbestrol represented a tremendous improvement over the use of natural estrogens. Natural estrogens were very expensive due to the extensive hormone isolation process and had to be injected into the buttocks with the frequent side effect of abscesses. DES was much less expensive and it could be administered orally.

Dr. Dodds was not connected with any drug manufacture but rather was working under a grant from the Medical Research Council of Great Britain. Most significantly, Dr. Dodds never patented DES which led to the manufacture of DES by many drug companies and to the tendency for doctors to prescribe the drug by its generic name (diethylstilbestrol).

REGULATORY AND LEGAL STANDARDS

Drug regulation began in the United States in 1890 with limitations on the importation of adulterated or unwholesome food, drugs, or liquors. This was followed by the Food and Drug Act of 1906 (“Wiley Act”) which provided the first direct regulation of drug manufacturers. However, the FDA was not created until passage of the first comprehensive statute in this area, the Federal Food, Drug, and Cosmetic Act of 1938, which remains the basis of United States drug law.

The next major change in United States drug laws was passage of the Kefauver-Harris Amendment of 1962. This, most importantly, amended Section 505 of the 1938 Act to require drugs be effective as well as safe. DES was originally approved and marketed under the 1938 Act.

Obviously, fulfilling the requirements of the FDA is a major concern of drug manufacturers. Compliance does not, however, fully end their legal responsibilities. The products liability laws of the various states become applicable when anyone is harmed by a drug. Evidence of compliance with FDA requirements may be presented to the jury to show proper care and adequate testing, but such compliance is not conclusive on this issue.

The law has made great strides to allow consumers legal redress against sellers and manufacturers. The law of products liability can be traced to the English case of Winterbottom v. Wright. This case led the way for the elimination of the privity requirement in tort actions. In 1963, in Greenman v. Yuba Power Products, Inc., a manufacturer was held strictly liable in tort for injuries sustained due to a defective product.  This case led the way toward the adoption of strict liability in tort.

The exposure of drug manufacturers can best be understood by analyzing Section 402A of the Restatement (Second) of Torts:

402A Special Liability of Seller of Product for Physical Harm to User or Consumer.

  1. One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate use or consumer, or to his property, if
    • the seller is engaged in the business of selling such a product,
    • and it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.
  2. The rule stated in Subsection (1) applies although
    • the seller has exercised all possible care in the preparation and sale of his product, and
    • the user or consumer has not bought the product from or entered into any contractual relation with the seller.

The Restatement, moreover, is accompanied by a number of comments and guidelines. Most important for purposes of this article is Comment K entitled “Unavoidably Unsafe Products,” which provides in pertinent part:

There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended or ordinary use. These are especially common in the field of drugs … Such a product, properly prepared, and accompanied by proper directions and warnings is not defective … It is … true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situations call for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attendant with a known but apparently unreasonable risk.

This exception recognizes the fact that drugs (and especially prescription drugs) cannot be made completely safe. This is in essence a decision that frequently the benefit and utility of the drug outweighs its risk, at least if proper warnings are given. Therefore, drug manufacturers are held to the duties of adequately testing their products and of adequately warning of known dangers. Some courts nevertheless have ruled that Comment K’s insulation is lost and strict liability applies

  1. where the drug could not reasonably have appeared to be useful and desirable at the time of manufacture
  2. or where, despite some apparent efficacy, the medically recognizable risk feasibly outweighed its utility.

Regardless of the result of a Comment K analysis, three essential requirements remain under traditional products liability doctrine in order for the plaintiff to recover. In order to recover, a plaintiff must show a product is defective, that the defective product is attributable to the party to be held responsible, and that the defect in the product caused the plaintiff’s injury. The second requirement has been articulated as the identification requirement. This is where the DES plaintiffs have the most problem. Due to the long time lapse since ingestion by their mothers, and poor recordkeeping by pharmacies and doctors, most plaintiffs “cannot identify the manufacturer of the drug ingested by their mothers.”  The identification requirement has clearly been a crucial element. It is a fundamental principle of products liability law that a plaintiff must prove, as an essential element of his case, that a defendant manufacturer actually made the particular product which caused injury.

DES plaintiffs face many problems, both legal and practical. Among the legal problems are: class action certification; the possible running of the statute of limitations; and denial of a cause of action because the injury was prior to birth or viability. The biggest obstacle, however, as already indicated, is the identification requirement. This is the area in which courts have created new doctrine and is the principle focus of this article.

MEDICAL AND REGULATORY HISTORY

As previously noted, DES was developed in 1937 by Dr. Dodds. Since it was not patented, many drug companies were interested in marketing it in the United States. In order to do so, a drug company had to file a New Drug Application (NDA) pursuant to § 505 of the Federal Food, Drug, and Cosmetic Act. The NDA had to state proposed uses (indications), clinical data and studies establishing the safety of the drug, chemical composition, manufacturing method, and proposed labeling.

The first NDA for DES was filed in 1939. Ten firms had made separate NDA filings by the end of 1940. These NDA’s were for the following indications: “the treatment of post-menopausal symptoms, senile vaginitis, gonorrheal vaginitis, and suppression of lactation.”

The FDA then decided to ask the drug companies to pool their clinical data. According to Dr. Theodore Klumpp, the Chief of the Drug Division of the FDA at that time:

It was feared that to consider each NDA separately would present “an overwhelming problem” and so it was decided, “in the public interest,” to request that the drug companies pool all their clinical materials and present them together. The companies apparently received this suggestion with little enthusiasm, but accepted it when it was pointed out that consideration of individually submitted data would mean delay in approving the applications. As a result, a committee, whose members represented the drug companies, was formed which put together and summarized all clinical data supplied by the individual pharmaceutical companies eventually presenting this data to the FDA.

The drug companies complied with this request and the “small committee” was formed in early 1941.

The FDA, nevertheless, made further requests of uniformity. The companies were required to use the same United States Pharmacopeia standard so that the active ingredients of all DES products were the same. The FDA also requested that uniform labeling (warnings and dosages) be used. Finally, the FDA requested that the companies include a “permissions clause” in their NDA’s. This clause allowed any company to refer to the “master file” of clinical studies in their NDA’s. In 1941, the FDA began approving the NDA’s for the four indications previously noted.

Meanwhile, research was begun in the 1940’s into the use of DES in the treatment of problems of pregnancy. Apparently, all research was originally done by independent medical researchers, although the drug companies later cooperated by supplying DES to the researchers.

In 1947, several drug companies submitted supplemental NDA’s in order to market DES as a miscarriage preventative. These applications referred to the independent research done, particularly that of Drs. 0. Smith and George Smith of Boston. The companies did not, however, conduct laboratory tests on pregnant laboratory animals. This later became a claim of inadequate testing in several DES cases.

The FDA began approving these NDA’s in 1947 based upon all available information. Eventually approximately 300 companies marketed DES in various dosages and for various indications.

In 1952 the FDA declared that DES was no longer a “New Drug” but was instead “generally recognized as safe” under § 201(p) of the 1938 Act. 4 This meant that a drug company could now enter the DES market without submitting an NDA, thus prompting a great number of manufactures to enter the market. The new companies had only to meet the manufacturing standards and to market the drug for the previously approved indications. During the period 1947-1971 DES was widely prescribed as a miscarriage preventative. It was estimated that between 500,000 and 2,000,000 pregnant women used the drug. High dosages were needed when DES was used as a miscarriage preventative. The most popular tablet for this indication was the 25 mg. size. Multiple tablets of lower dosages, primarily 5 mg. and 10 mg., were also probably prescribed.

In 1967, the National Academy of Sciences-National Research Council (NAS-NRC) completed its review, required by the 1962 Drug Amendments, 9 of the efficacy of DES. The NAS-NRC rated DES as “possibly effective” as a miscarriage preventative. The FDA, however, delayed further action until 1971.

By 1971, the link between DES used in pregnancy and the development of vaginal cancer in DES exposed daughters was well demonstrated. This form of cancer, adenocarcinoma, is rare, and in fact the incidence rate in DES exposed daughters is still fairly low. There have been approximately 250 reported cases of adenocarcinoma in DES exposed daughters. Further, although the disease is serious, its treatment is extremely effective if it is detected in its early stages.

DES daughters, nevertheless, suffer from other health problems as well. The most common is adenosis, which is the abnormal presence of glandular tissue in the vagina. Current research indicates that adenosis is not a precancerous condition and that it may tend to disappear over time. Apparently, daughters exposed earlier in pregnancy have a higher incidence of adenosis. DES daughters have also developed structural abnormalities other than adenosis. Furthermore, there is a slightly increased risk of an unfavorable pregnancy (for DES exposed daughters) according to the National Cooperative Diethylstilbestrol Adenosis Project (DESAD Project). There does not, however, appear to be any carryover to the children of DES daughters as of yet, although research is continuing. There have been some reports of noncancerous abnormalities of DES exposed sons, but, it does not appear that there is any cancer risk.

In 1971, the FDA issued a warning which required a labeling change which contraindicted the use of DES during pregnancy.  By contraindicting the use of DES as a miscarriage preventative, the FDA removed its approval of the drug for that use.

Thus, after 1971 DES was no longer used as a miscarriage preventative. It is very hard not to sympathize with the DES plaintiffs, especially those who have developed adenocarcinoma. Yet, DES should not be viewed as a total mistake. It is still an approved drug for many indications, and several companies still produce it, although in lower dosages.

DES LITIGATION

The number of pending DES suits is tremendous. There are over 1,000 suits pending today. As one writer observed, given the magnitude of the potential liabilities, these DES cases in the aggregate appear to this writer very much like a tidal wave, still miles out to sea, but sweeping inexorably toward shore.

Further, these products liability actions appear to be an inefficient method of compensating the plaintiffs. In a general drug products liability suit, one observer estimated that the plaintiff receives only thirty cents out of a dollar after attorney fees and costs are deducted. As we have seen, DES cases are even more complicated than the average drug case. The defendant drug manufacturers obviously do not fare well either. The minimum defense costs of a “simple” DES case has been estimated at $50,000. The national total in claims alone could reach $40 billion.

Defendants have prevailed in the vast majority of DES cases decided to date; the usual reason being the plaintiffs’ failiure to identify the manufacturer. The plaintiffs have attempted to overcome this obstacle by asserting two traditional theories, alternative liability and concert of action, as well as proffering two novel theories. The first of these novel theories was initially presented in a 1978 law review comment entitled “DES and a Proposed Theory of Enterprise Liability.” This excellent and often-cited article began the trend toward enterprise or market share liability. The second development was the California case of Sindell v. Abbott Laboratories .  Sindell proposed a market share approach to the DES identification problem. Sindell will first be discussed since it contains a discussion of all of the proposed theories.

Sindell

In Sindell the Supreme Court of California held four-to-three that the plaintiff’s action should not have been dismissed solely because the plaintiff could not identify the manufacturer of the DES they had been exposed to in utero. Instead of requiring specific identification, the Court said that upon a showing that the manufacturers joined as defendants produced a substantial percentage of the drug in question each manufacturer would be held liable for his share of the market.

In dissent, Judge Richardson noted practical and theoretical deficiencies in the majority’s reasoning. The dissent felt that such a drastic change in products liability law should have a legislative rather than judicial source. By obviating the required proof of cause-in-fact, the dissent observed that Sindell was indeed “a new high watermark in tort law.”

Plaintiff Judith Sindell brought suit against eleven drug companies and 100 “Does.” She sued on behalf of herself and on behalf of all similarly situated women of California. She developed a malignant bladder tumor which was surgically removed, and suffers from adenosis. Sindell stated that she was unable to identify the manufacturer, and her case was therefore dismissed at trial.

The Sindell opinion recognizes the plight of the plaintiff who cannot meet the identification requirement. It must be remembered that the identification problem in DES cases is due to the long latency period before the adverse reactions develop, the delay before the cancer relationship was established, and the fact that DES tended to have been marketed generically.

Sindell then analyzed the case under several theories. It rejected the following: alternative liability; concert of action; and enterprise liability. Each of these theories will be examined in later sections of this article.

After finding existing theories inapplicable, Sindell fashioned a new theory, market share liability. The Court, nevertheless, stated that the theory is merely a modification of the alternative liability theory of Summers v. Tice. The Sindell majority boldly based its market share theory on the policy grounds that “as between an innocent plaintiff and negligent defendants, the latter should bear the cost of injury.” Justice Mosk observed:

In our contemporary complex industrialized society, advances in science and technology create fungible goods which may harm consumers and which cannot be traced to any specific producer. The response of the courts can be either to adhere rigidly to prior doctrine, denying recovery to those injured by such products, or to fashion remedies to meet these changing needs.

Fashion a remedy they did. Under the market share liability theory, plaintiffs are required to join a “substantial share”  of DES manufacturers and prove that each was negligent. Each defendant is then allowed to show that his product could not have caused the plaintiff’s harm. If not absolved, each defendant will be liable “by the percentage which the DES sold by each of them for the purpose of preventing miscarriage bears to the entire production of the drug by all for that purpose.

The dissent too felt sorry for the plaintiffs, but felt that the majority’s solution was too large a break from prior doctrine. Justice Richardson stated:

The majority adopts a wholly new theory which contains these ingredients: The plaintiffs were not alive at the time of the commission of the tortious acts. They sue a generation later. They are permitted to receive substantial damages from multiple defendants without any proof that any defendant caused or even probably caused plaintiffs’ injuries.

The dissent would abide by prior case law which required identification unless the case fell within one of the exceptions that California recognizes, which even the majority dismissed as inapplicable.

Since the plaintiff joined only five drug manufacturers, the dissent observed that it was far from certain that the manufacturer who actually caused the injuries was joined. The majority countered this by their “substantial percentage” requirement and by noting that the plaintiff claimed that Eli Lilly and five or six other producers accounted for 90 percent of the DES market. The dissent further argued that by having only 5 of 200 manufacturers, the alternative liability theory or its derivatives should be inapplicable.

The dissent would adhere to the requirement that causation in fact be proven. Justice Richardson felt courts should resist the “deep pocket theory of liability” and further observed that plaintiffs who could not make a specific identification would be rewarded by “being offered both a wider selection of potential defendants and a greater opportunity for recovery.” In addition, Justice Richardson continued his assault by asserting:

The “market share” thesis may be paraphrased. Plaintiffs have been hurt by someone who made DES. Because of the lapse of time no one can prove who made it. Perhaps it was not the named defendants who made it, but they did make some. Although DES was apparently safe at the time it was used, it was subsequently proven unsafe as to some daughters of some users. Plaintiffs have suffered injury and defendants are wealthy. There should be a remedy. Strict products liability is unavailable because the element of causation is lacking. Strike that requirement and label what remains “alternative” liability; “industry-wide” liability, or “market share” liability, proving thereby that if you hit the square peg hard and often enough the round holes will really become square, although you may splinter the board in the process.

The dissent concluded by observing the “omnious ramifications” of the majority’s theory. It questioned whether the pharmaceutical industry should be made an insurer for any and all injuries attributable to drugs. Justice Richardson suggested that a legislative approach would be preferable, in particular a system “which would establish and appropriate funds for the education, identification, and screening of persons exposed to DES, and would prohibit health care and hospital service plans from excluding or limiting coverage to person exposed to DES.

Alternative Liability

The case of Summers v. Tice created the theory of alternative liability, or double fault and alternative liability. In Summers, two hunters simultaneously and negligently fired their guns in the same direction. One bullet hit their companion, the plaintiff Summers. Clearly only one of the defendants actually caused the injury, but identification was not possible. The Court therefore shifted the burden of proof or cause-in-fact to the defendants. If they could not absolve themselves, joint and several liability results.

The “DES Comment” argued that alternative liability could be used to solve the DES identification problem. The author, however, admits that the reasoning must be strained a bit, but concludes that the theory is viable on policy grounds since the plaintiffs are innocent and the defendants were all tortfeasors.

Other commentators have rejected the alternative liability theory for DES cases. The chief reason why Summers should not apply is that in Summers all the potentially responsible parties were joined, this is clearly not true in the DES cases. Indeed, it is quite possible that the actual defendant would not be before the court.  Other distinctions include that in Summers, the negligence caused the identification problem, yet in the DES cases the problem was largely caused by the lapse of time, and in Summers, the defendants arguably had better access to the information than the plaintiff, although this is more ques- tionable in the DES cases.

The Sindell majority rejected the alternative liability theory for many of these same reasons. The key reason was that not all possible responsible parties were joined. The Court also considered, but did not rest its decision on, the fact that the defendants had no greater access to information which might facilitate identification. It must be remembered that this is the Court that decided the key precedents for the alternative liability theory, Ybarra v. Spangard and Summers v. Tice, and it found the theory inapplicable to DES cases.

It seems clear that alternative liability cannot be the solution to the DES identification problem. The one authority which justified it, the “DES Comment,” did so only as an alternative to its main proposed theory. As one author stated:

Applying the theory of alternative liability to DES litigation, wherein an entire industry may be held liable for an unforeseeable reaction to a product arguably produced in the public interest, goes far beyond the circumstances of a nonrecurring hunting accident. In the context of DES litigation, the benefit of alternative liability to the plaintiff’s ultimate recovery may strain the very notion of “fairness” upon which the Summers decision was based.

Nevertheless, some courts, including the lower court in Sindell, have employed the alternative liability theory in DES cases. One case, Abel v. Eli Lilly & Co., held that the theory stated a sufficient cause of action, and another, Ferrigno v. Eli Lilly, used alternative liability in fashioning a market share approach. It must be noted that Ferrigno was severly criticized in a subsequent case also before the New Jersey Superior Court, Namm v. Frosst and Co. Namm flatly rejected the theory of alternative liability.

Concert of Action

The concert of action theory is based upon the requirement of a “common plan or design to commit a tortious act. Actual agreement is not necessary, but the court must find a tacit understanding and tortious acts pursuant to the common plan. As with alternative liability, the defendants under a concert of action theory are held jointly and severally liable.

The classic fact situation for concert of action to be applied is the illegal drag race. The agreement or tacit understanding can be inferred from the parallel conduct of the participants.

This theory was argued in Sindell, and the “DES Comment” also argues it as a viable theory for DES cases. The “DES Comment” argued that the case of Hall v. E. L DuPont De Nemours & Co., supports this position. In Hall, thirteen children were injured by the explosion of dynamite blasting caps. The specific manufacturer could not be identified since all markings on the caps were destroyed in the explosion. The plaintiffs, therefore, sued the six American manufacturers of blasting caps and their trade association under the concert of action theory. The court held for the plaintiffs upon finding that the manufacturers had known of the dangerous nature of their product but had agreed among themselves not to place warnings on the caps. The effect of this holding was to shift the burden of proof on identification to the defendants. The “DES Comment” author contends that, in the DES situation there is enough conscious parallel behavior involved in the pooling of clinical data and other cooperative activity by the drug manufacturers in 1941 to find concerted action.

The Sindell Court nevertheless refused to apply the concert of action theory because they could not find a tacit understanding or a common plan among the drug manufacturers. Most of the activity alleged to be parallel was indeed required by law. Justice Mosk admitted:

Application of the concert of action to this situation would expand the doctrine far beyond its intended scope and would render virtually any manufacturer liable for the defective products of an entire industry, even if it could be demonstrated that the product, which caused the injury was not made by the defendant.

A good reason not to apply the concert of action theory is the pervasive regulation by the FDA. The testing, manufacturing, and marketing of drugs is all highly regulated. Further, Hall is clearly distinguishable from the DES situation. In Hall, the entire industry was joined as it consisted of small number of firms, and the identification problem in Hall was caused by the explosion itself.

Although most courts have rejected the concert of action theory in DES cases, the theory has, nevertheless, found some support. The lower court in Sindell applied this theory as well as alternative liability. In Bichler v. Eli Lilly & Co., a case involving a DES action against only that named manufacturer, the New York appellate court ruled there was sufficient evidence to support the jury’s finding of concerted action. The reasoning of this case has been criticized, in particular because of the reliance placed by the court upon parallel activity by the drug companies prior to their efforts to seek approval of DES as a miscarriage preventative. Another DES case, Abel v. Eli Lilly & Co., approved the concert of action theory as having stated a cause of action which should go to the jury.

Enterprise Liability

Enterprise liability is the term used for the theory developed by the author of the “DES Comment.” According to the author, it is available whenever the plaintiff cannot identify the cause-in-fact of the injury. The elements of enterprise liability as stated are:

  1. Plaintiff is not at fault for his inability to identify the causative agent and such liability [sic] is due to the nature of the defendant’s conduct.
  2. A generically defective product was manufacturered by all the defendents.
  3. Plaintiff’s injury was caused by this product defect.
  4. The defendants owed a duty to the class of which plaintiff was a member.
  5. There is a clear and convincing evidence that plaintiff’s injury was caused by the product of some one of the defendants. For example, the joined defendants accounted for a high percentage of such defective products on the market at the time of plaintiff’s injury.
  6. There existed an insufficient, industry-wide standard of safety as to the manufacture of this product.
  7. All defendants were tortfeasors satisfying the requirements of whatever cause of action is proposed: negligence, warranty, or strict liability.

Enterprise liability was developed specifically for the identification problem of the DES cases. After proving these elements the burden of proof or causation is shifted to the defendants. Any defendant can then absolve himself by showing that his product could not have caused the injury. In order to meet the clear and convincing evidence standard of element number five, a plaintiff must join manufacturers of “a high percentage of the defective products on the market, approximately 75% to 80%.

This theory was designed to correct some of the logical inconsistencies found when trying to fit DES cases into concert-of-action or alternative liability theories. The author justifies the theory upon a basic policy argument that the United States drug industry, as a whole, caused this problem and that it, therefore, should be liable. Further, the author stated that by the use of selfinsurance and captive insurers, the drug industry can better afford to pay the cost. Other policy arguments include: that enterprise liability would provide incentives for the drug companies to improve their testing and adverse reaction reporting systems; that the drug industry is financially sound and can easily afford these losses; that drug companies presently do not spend sufficient amount of funds on research and development; and that any losses could be easily passed along to the consumer through higher prices.

The Sindell court rejected enterprise liability by first distinguishing Hall, upon which the theory relies. Justice Mosk felt that the differences between a six-member blasting cap industry and the DES industry of over 200 firms were simply too great. Most importantly, however, the Sindell majority felt that it was unfair to condemn the industry for standards which were so highly compelled by the federal government. Justice Mosk stated:

But since the government plays such a pervasive role in formulating the criteria for the testing and marketing of drugs, it would be unfair to impose upon a manufacturer liability for injuries resulting from the use of a drug which it did not supply simply because it followed the standards of the industry.

There are also several policy considerations which argue against the theory of enterprise liability. It remains questionable whether a drug manufacturer should be held liable for a product which only “could” have caused the injury. As already noted, plaintiffs who cannot identify the manufacturer will be favored over those who can by having a larger pool of defendants. Further, expansion of manufacturers’ liability will further increase the cost of products liability insurance, if it is indeed available at all. It is highly questionable whether liability here will serve any deterence function since the injuries were arguably not foreseeable to begin with. Apparently, no court has adopted the enterprise liability theory as proposed in the “DES Comment.

Market Share Liability

As previously discussed, Sindell created the theory of market share liability. Justice Richardson, in dissent, aptly recognized that although the majority rejected enterprise or industry-wide liability, the difference between it and the majority’s market share liability was a difference of form rather than substance.

The theories are not, however, identical. As already noted, enterprise liability requires a 75-80% joinder while Sindell requires only a “substantial share.” The theoretical differences of each theory have been observed by many commentators. One writer observed that allocatoin under enterprise liability is based on a national market, the Sindell approach is presumably based on the California market. Similarly, each defendant under enterprise liability faces joint and several liability, while under Sindell he arguably only faces liability for his proportional share of the market. This can lead to profound differences to defendants and to plaintiffs.

CONCLUSIONS AND RECOMMENDATIONS

The extensive efforts made by courts and commentators to expand traditional products liability and tort doctrines to solve the identification problem faced by DES plaintiffs are understandable. As one writer observed, “Sindell is a classic example of the admonition that hard cases make bad law. While pursuing a noble motive – the compensation of innocent victims of adverse drug reactions – the Sindell court gravely overstepped the boundaries of judicial lawmaking. The same, of course, can be said for the enterprise liability theory and the alternative liability and concert of action theories which are logically inapplicable anyway.

The most basic reason to resist these theories is the tremendous break they make from prior law. The causation issue is such a fundamental requirement of products liability law that it should not be eliminated. As Dean Prosser noted: the plaintiff must introduce evidence which affords a reasonable basis for the conclusion that it is more likely than not that the conduct of the defendant was a substantial factor in bringing about the result. A mere possibility of such causation is not enough ….  These theories similarly have extended potential liability so far that a particular defendant may be held proportionately liable even though mathematically it is much more likely than not that it played no role whatever in causing plaintiffs’ injuries.

Extension of liability here would severely strain the drug companies’ ability to obtain adequate insurance coverage. Products liability insurance rates for United States drug companies already reflect the tremendous liability exposures. In fact, many United States drug companies have already been forced to self-insure because insurance companies are unwilling to underwrite these risks. The risks are large enough that at least one company is now viewed as a poor investment risk.

Despite protestations to the contrary, United States drug manufacturers do put forth great amounts of effort and resources into research and development. Public policy obviously favors the development of new drugs, but as each new product faces huge and seemingly unlimited liability, the incentive to continue research is reduced. One writer analyzed the harm done society as strict liability is imposed:

There are two risks involved in the development of new drugs:

  1. the risk that unforeseen, perhaps catastrophic, injuries will result because a new drug is used in man too soon;
  2. and the risk that needless human suffering and death will occur because a beneficial drug is withheld from mankind too long. Absolute liability for the adverse effects of new drugs would enlarge the latter risk to unacceptable proportions, while giving a remedy to those injured by the former risk.

Thus, society as a whole is better off by not further expanding our products liability laws in this setting.

Further doctrinal expansion will serve only a compensation function and not a deterrence function. If we are to hold drug companies liable for latent defects in their products, then we should at least leave the causation burden with the plaintiff. In this way the defendant who caused the harm would be the one deterred.

As already noted, defense costs in DES cases are high, and the actual amount received by plaintiffs low. This points up the tremendous costs of using the legal system to solve this problem. The DES cases are very complicated, legally and medically. The costs mount up with each new case, a new jury, a new judge, and often new attorneys must be taught the unique facts of a DES case.

The market share and enterprise liability theories were developed for the DES cases, but their impact could extend much further. It was observed that Sindell is potentially applicable in any case where identification of the manufacturer is impossible or where a generically similar defective product is produced by multiple manufacturers. An especially likely area of exportation would be the over 6,000 already pending cases involving asbestos.

TOWARD A PRINCIPLED APPROACH

FDA Regulation

While it cannot compensate the victims, the FDA should be allowed to continue to regulate the drug industry. The suggestions to let products liability actions take the place of federal regulation seem ludicrous in the DES context.

Were DES introduced today for the use of preventing miscarriages it would surely not be approved by the FDA. While the benefit of hindsight is difficult to ignore, the FDA’s testing procedures have been vastly improved since the 1940’s. The tests done in the 1940’s did not generally include possible effects on a fetus, although today the FDA would certainly require such studies, especially for a drug meant to be given to pregnant women. DES would not be approved today for use as a miscarriage preventative for the additional reason that the drug has been proven not effective for that use. Since the KefauverHarris Amendments of 1962, drugs must be safe and effective to receive FDA approval.

Legislative Solutions

Many observers have suggested a no-fault insurance system for product injuries. Even the “DES Comment” recommended this, but recognized it was within the province of the legislature.

Most of these proposals would apply to all industries. One especially notable proposal appears in a 1979 law review comment. The author proposes a “latent technological injury compensation” system where an injured party could go to an administrative body for relief if his injury was not discoverable within a certain specified period after initial purchase. After this “statute of limitations” ran, the plaintiff would lose his tort or products liability actions. The plaintiff would be compensated by the administrative body upon: showing that she was injured; tracing her injury to a type of product; and showing her injury was not discoverable during the statutory period. Compensation would be for bodily injuries including medical expenses and lost earnings but not for pain and suffering. This system would be funded by a uniform tax on all manufacturers.

While this system has much to commend it, the authors would prefer a system limited to the DES situation. Other industries and products, such as asbestos, could be added later as the legislature saw fit. Such a system would be similar to the one suggested by Justice Richardson in Sindell. It is believed, however, that a national system would be preferable to a state-by-state approach.

This proposed national system should be funded by a tax upon the manufacturers who produced DES for use as a miscarriage preventative. The tax should be equitably imposed upon them, most probably based upon total national market share. While it is true, that this will involve some of the same difficulties presented by the Sindell approach, figures for such a national market are already available. As with the “latent technological injury compensation system” discussed earlier, recovery should be limited to medical expenses and lost earnings and it would, of course, displace other remedies. Hopefully, the cooperation of the drug companies could be obtained since they have much to gain by the system, most importantly avoiding needless defense costs and possible awards for pain and suffering.

In conclusion, Sindell and the enterprise liability proposal were indeed noble efforts to compensate the innocent victims of DES exposure. It is hard to imagine plaintiffs more innocent than those who were exposed to the drug before their birth. The judicial theories, however, wreak too much havoc upon our legal doctrines. The solution must be of legislative origin, not judicial. The DES identification problem must be answered finally by a policy decision. The difficulties and adverse effects of a judicial solution make the legislative one preferable.

Barry S. Roberts and Charles F. Royster, Winter 1983.

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Daughters at Risk : a Personal DES History

image of daughters-at-risk book
Anne Needham, who as a young DES Daughter had a hysterectomy for cancer, sued White Laboratories, makers of a DES drug. Lawrence S. Charfoos – an attorney in the litigation – and Stephen Fenichell detail the case and provide a history of DES development, research linking it early to cancer, the FDA’s approval, the pharmaceutical company promotion, and the medical community’s involvement.

This is the legal story of one of the first DES cases to go to trial, as told by the plaintiff’s lawyer and a journalist covering the case; and it conveys neither the victim’s feelings nor the drama of the experience.

Anne Needham was 20 when operations for the rare vaginal cancer now appearing in DES daughters left her unable to bear children, partially incontinent, and emotionally in turmoil. Six years later an Illinois court awarded her $80,000 in damages ; a decision that was reversed on appeal and remanded for trial; and there the story ends.

The authors competently recount the development of DES in England; its popularization by the Smiths of Harvard as a drug to ward off miscarriage; how the first cases of vaginal cancer were connected to DES; and the role of the FDA.

It seems however that “the particulars of Anne Needham’s personal ordeal and of the trial are vague and incomplete” and that “at the trial, the importance of the legal maneuvering is never quite established“.

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1978 DES Case: Gray v. Eli Lilly & Co. and the United States

ABSTRACT

This is a civil damage suit brought by the plaintiff, Beverly Ann Gray (Gray), against a drug company, Eli Lilly and Company (Lilly), and the United States. Plaintiff alleges that she has been harmed by a drug diethylstilbestrol (DES), taken by her mother during Gray’s period of gestation. The pleadings and affidavits indicate that DES was dispensed by physicians in the early 1950’s to pregnant women with histories of miscarriages in order to avoid problem pregnancies. It was not until 1971 that the medical community recognized that DES caused cancer in women whose mothers took the drug. This is the basis of Gray’s complaint. In essence this is a products liability case. Gray sues Lilly as the manufacturer of the drug and the United States for its approval, through the Food and Drug Administration (FDA), of the sale of DES without warning of its adverse effects. The case is now before the court on motions for summary judgment by Lilly and the United States.

GRAY v. UNITED STATES, Leagle, decision/1978782445FSupp337_1743, February 2, 1978.

Lilly contends that the plaintiff has failed to identify it as the particular manufacturer of the drug, DES, which caused her injury. It is a fundamental principle of products liability law that a plaintiff must prove, as an essential element of his case, that a defendant manufacturer actually made the particular product which caused injury. In Wetzel v. Eaton Corporation, the plaintiff sued two corporations which were the only suppliers of a defective tractor part prior to the injury in question. The plaintiff, however, could not produce any evidence identifying the particular defendant that supplied the defective tractor part. The court held that summary judgment was appropriate for the moving defendant since it would be only speculation and conjecture that might link any one of the two defendants to the defective part.

It is apparent that Gray is unable to identify Lilly as the particular manufacturer of the DES taken by her mother. In 1953 and 1954 there were at least one hundred separate companies offering to sell some form of DES. Gray, of course, cannot of her own knowledge identify which of these one hundred companies manufactured the drug taken by her pregnant mother. Gray’s mother has testified that she cannot identify what brand of DES she took, nor can she remember the shape, color or dosage of the DES ingested. Dr. Charles F. Beckert who treated Mrs. Gray during her pregnancy and who prescribed DES for her use from October 19, 1953 to April 26, 1954 cannot identify the manufacturer of the DES taken by Mrs. Gray. Mr. Charles Wesley Gray, plaintiff’s father, does not remember the size, shape, color or manufacturer of the DES taken by Mrs. Gray. Mr. Vernon C. Thompson, former co-owner of the drug store where Mrs. Gray’s DES prescriptions were filled, cannot identify which manufacturer’s DES was used to fill Mrs. Gray’s prescriptions. The present owner of such drug store, Hugh Allen Johnson, destroyed all prescription records for the years prior to 1956 due to insufficient storage space, and cannot identify the manufacturer of the DES taken by Mrs. Gray. It has been over three years since Gray filed her original complaint, and well over a year since the critical issue of the manufacturer’s identity was raised by Lilly’s amended motion for summary judgment. Gray has had ample time for discovery, but has failed to provide any proof on this essential element of her case. Lilly’s motion for summary judgment must be granted.

The United States has moved for summary judgment on the basis of a statutory exception to the Federal Tort Claims Act. The exception relied upon is in 28 U.S.C. § 2680(a) which states:

The provisions of this chapter and section 1346 of this title shall not apply to . . . Any claim based upon an act or omission of an employee of the Government, exercising due care, in the execution of a statute or regulation, whether or not such statute or regulation be valid, or based upon the exercise or performance or the failure to exercise or perform a discretionary function or duty on the part of a federal agency or an employee of the Government, whether or not the discretion involved be abused.

It is clear that this statutory exception from the Federal Tort Claims Act bars recovery for acts which constitute discretionary functions of government officials. In her original complaint, plaintiff alleges that the United States government, through its agent, the Food and Drug Administration (FDA), was negligent in failing properly to test DES, in failing to warn of the adverse effects of DES, and in approving DES and representing that it was safe. The new drug provisions of the Federal Food, Drug and Cosmetic Act state that a drug which is not generally recognized by qualified experts as safe and effective under the conditions for which it is prescribed, recommended or suggested, may be shipped in interstate commerce only if an approval of a new drug application is effective for that drug. The function of the Food and Drug Administration was to approve the new drug application for DES pursuant to 21 U.S.C. § 355(d). That section required the Secretary to determine whether:

  1. the investigations, reports of which are required to be submitted to the Secretary pursuant to subsection, do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof;
  2. the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions;
  3. the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity;
  4. or upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, he has insufficient information to determine whether such drug is safe for use under such conditions; . . . he shall issue an order refusing to permit the application to become effective. ” …

… continue reading GRAY v. UNITED STATES. on Leagle.

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1981 DES Case: Bichler v. Eli Lilly & Co.

Abstract

” Plaintiff Joyce Bichler brought this product liability action against defendant Eli Lilly and Company (Lilly) and two other defendants for damages sustained by her as a result of the use of the prescription drug diethylstilbestrol (DES), a synthetic estrogen, which her mother ingested in 1953 while pregnant with plaintiff.

At the age of 17, plaintiff was diagnosed as having carcinoma of the cervix and vagina. In 1972, she underwent a radical hysterectomy which removed her ovaries, both fallopian tubes and two thirds of her vagina. As a result of that operation, she cannot bear children and, as she has testified, her sexual relations with her husband are also impaired.

In 1974, she and her father brought this action against Lilly as the alleged manufacturer of the DES pills plaintiff’s mother ingested, and against two other defendants who are no longer parties to the action. The claims of Mr. Bichler, the father, were barred due to the running of the Statute of Limitations.

BICHLER v. ELI LILLY & CO., Leagle, decision/198139679AD2d317_1351, February 24, 1981.

A bifurcated trial was ordered by the trial court at Lilly’s request. The first, a trial on the issue of manufacturer identification, commenced in May, 1979. At this identification trial, the jury found that plaintiff had not established by a fair preponderance of the credible evidence that defendant Lilly was the manufacturer of the DES pills her mother had taken. DES, as a generic drug, was, and still is, manufactured by a number of drug companies. Lilly dominated the market at the time DES was approved by the Food and Drug Administration (FDA) and at the time plaintiff’s mother used it.1 As a major producer of the drug, Lilly also sold DES in bulk to other drug companies for use under their own names, a common practice in the drug industry. The pills Mrs. Bichler ingested were not identifiable by any markings. The dispensing pharmacist testified at this trial that he had stocked DES from four or five manufacturers, including Lilly, but was not able to recall, nor did he have the records to establish, which pills he chose to fill the prescription for plaintiff’s mother. Plaintiff appeals from this verdict as against the weight of the evidence and claiming other errors committed by the trial court.

First, although the trial court did conduct most of the voir dire itself, objection to that practice is rendered meaningless where, as here, the record is clear that counsel for both parties had ample opportunity to scrutinize prospective jurors. Secondly, no prejudice to either party is shown by the fact that the court, after a thorough questioning by himself and both counsel, permitted a pharmacist’s wife to become a juror. We find it significant that in this instance plaintiff did not challenge the juror for cause. We also find plaintiff’s other claims of error to be without merit and further hold that upon review of the record, the jury’s finding that Lilly was not proven to be the manufacturer of the DES pills ingested by Mrs. Bichler is not against the weight of the evidence.

Plaintiff, in her amended complaint, had claimed in the alternative that Lilly could be found liable even if it had not manufactured the DES Mrs. Bichler ingested. At the second trial, on this issue, the jury answered seven interrogatories, found Lilly liable and awarded damages in the sum of $500,000, plus costs, disbursements and interest. The verdict was reduced by the amount of a settlement with defendant doctor who prescribed the drug. In this second phase of the action, plaintiff proceeded against Lilly alone, as a tort-feasor jointly and severally liable. Plaintiff did so on an expanded theory of concerted action claiming Lilly and other manufacturers of DES did wrongfully test and market this drug for treatment of accidents of pregnancy. Lilly appeals from that part of the judgment based on the second verdict. ” …

… continue reading BICHLER v. ELI LILLY & CO. on Leagle.

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Compensation for Drug Injury

In 1957 Mr Greenman, an American, was working with a Shopsmith, a tool that could be used as a saw, a drill, and a lathe, when a piece of the wood he was working on flew out and injured him. About a year later he brought an action against the retailer, and the manufacturer, Yuba Products Inc. He claimed breach of both “implied” and “express” warranty and negligence. Express warranty is when a seller makes a specific promise about his products, such as “This drug has no known side effects.” Implied warranty is a warranty which the law reads into every sale whereby a seller represents that his products are of merchantable quality and reasonably fit for their purpose. Mr Greenman’s case against the retailer was not upheld, but the jury found against the manufacturer and awarded $65 000 damages. Both Mr Greenman and the manufacturer appealed. The Californian Supreme Court in 1963 upheld the lower court’s decision. Justice Traynor wrote in his judgment:

Compensation for Drug Injury, Product liability all dressed up American style, BRITISH MEDICAL JOURNAL VOLUME 282, NCBI PubMed, PMC1505432, 9 May 1981.

A manufacturer is strictly liable when an article he places on the market, knowing that it is to be used without inspection for defects, proves to have a defect that causes an injury to a human being…. The purpose (of imposing strict liability on manufacturers) is to insure that the costs of injuries resulting from defective products are borne by the manufacturers that put such products on the market rather than by the injured persons who are powerless to protect themselves…. To establish the manufacturer’s liability it was sufficient that the plaintiff proved that he was injured while using the Shopsmith in a way it was intended to be used as a result of a defect in design and manufacture of which the plaintiff was not aware that made the Shopsmith unsafe for its intended use.”

A plaintiff had to prove only that he was injured because of a defect in a product: he had no need to prove negligence on the part of the manufacturer. Thus strict liability in tort for product induced injury appeared in the United States.

Restatement of Torts

In 1965 the American Law Institute drafted the Restatement (Second) of the Law of Torts. Stimulated by the Greenman case it included the principle of strict liability for product induced injury in Section 402A, which states:

  1. One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if:
    • (a) the seller is engaged in the business of selling such a product, and
    • (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.
  2. The rule stated in Subsection (1) applies although:
    • (a) the seller has exercised all possible care in the preparation and sale of his product, and
    • (b) the user or consumer has not bought the product from or entered into any contractional relation with the seller.

Two comments on the section are particularly relevant to prescription drugs.

Where, however, the product contains an ingredient to which a substantial number of the population are allergic … the seller is required to give warning against it, if he has knowledge, or by the application of reasonable, developed human skill and foresight should have knowledge, of the presence of the ingredient and its danger… Where warning is given, the seller may reasonably assume that it will be read and heeded; and a product bearing such a warning, which is safe for use if it is followed, is not in defective condition, nor is it unreasonably dangerous.

There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs…. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.

Thus a manufacturer was liable for all injuries resulting from drugs not made to the design specifications even if he had taken as much care as possible. He was not, however, strictly liable in most cases when the drug was made exactly to design specifications yet still injured the patient. Only if he had failed to warn of a side effect that he should have known about was he liable, and this effectively was the same as negligence. Similarly, the manufacturer needed to warn only of side effects that were foreseeable in a “substantial number” of users. Some courts-particularly in California-have now begun, however, to move beyond the Restatement and find manufacturers liable in cases where the design of a drug was defective. The complexities of the law may be illustrated by considering a few cases.

Claims against manufacturers

If a drug is not manufactured to the design specification and it injures somebody the manufacturer will be liable under negligence, breach of implied warranty, and strict liability. Most manufacturers are willing to accept this kind of liability, and it presents few legal problems.

Design defect, when a drug is developed, then tested as fully as possible, manufactured to specification, yet injures people after being put on to the market, is the crucial issue in product liability. Drug manufacturers are usually willing to accept liability for production defects and failure to warn, but they balk at liability without fault for design defects. Lawyers and consumers also think that design defects are the most important, and after thalidomide, practolol, and now diethylstilboestrol (DES) this is where they have concentrated their reforming energy.

The Debendox case, which has received much publicity, is an example of a case over an alleged design fault. Debendox (sold as Bendectin in the United States) is an antinausea drug manufactured by Richardson-Merrell for use in pregnancy. It has been sold in the United States for 23 years, and an estimated 30 million pregnant women throughout the world have taken the drug. In the last two years, however, some people have suggested that the drug may cause congenital malformations. Many lawsuits have resulted, and although a panel of the Food and Drug Administration has agreed unanimously that there is no demonstrated association between Bendectin and birth defects, these suits continue.

The first case to come to court was that brought by Michael and Elizabeth Mekdeci in Florida in 1980. They alleged that their son David was injured by the drug, and they sued Richardson Merrell for $12m. The court’s decision was a peculiar one, and was interpreted by both sides as a victory. The jury decided that nothing should be awarded to the boy and no damages should go to the parents, but the parents should receive $20 000 for medical expenses. A Federal judge overturned this decision on the grounds that it was inconsistent: if the jury thought the drug caused the injuries they should have awarded damages, if they did not think it did they should not have awarded anything. The case was retried, and the jury agreed unanimously that the drug had not caused the injuries. Although the original decision was clearly illogical, it is easy to imagine the jury’s thinking: they were unconvinced by the evidence, but they thought that a rich drug company would not miss $20 000, which would help the boy and his parents enormously.

Diethylstilboestrol: America’s thalidomide?

The DES cases are the most recent and most interesting drug liability cases in the United States. They have excited some lawyers, who see the legal changes made by the cases as revolutionary, and they have worried the drug companies.

Stilboestrol was first synthesised in 1937 in Britain. It was the first synthetic, non-steroidal, oestrogen-like substance, could be taken orally, and cost about 1/300th of the cost of natural oestrogens. A patent was not applied for. A dozen drug companies in the United States tested the drug and applied to the Food and Drug Administration for a licence to market the drug for a variety of uses-none of which concerned pregnancy. Licences were granted in the autumn of 1941. At that time a drug application would usually contain reports on about 150-300 patients. Applications to market DES included reports on more than 5000 patients, none of whom were pregnant. Doctors knew, however, that high doses of any oestrogen could cause cancer in rats, and the warnings of some companies suggested that the drug should be avoided in patients with cancerous or precancerous lesions of the breast or cervix.

In 1947 the FDA began to give permission for the drug to be used in treating women with problem pregnancies, particularly those who had early miscarriages. In 1952 the FDA allowed any company to market DES without needing to make a further application. By 1953 148 companies were manufacturing the drug, and since then about 300 companies have marketed it; about a third of those companies no longer exist. DES gained its peak use in problem pregnancies in the early ’50s, but its use had fallen sharply by 1960, when progesterone became available. The drug is estimated to have been used in about 1 million pregnancies in America.

In 1971 Dr Arthur Herbst and others reported a statistical association between mothers being given DES in pregnancy and their daughters subsequently developing clear cell adenocarcinoma of the vagina and cervix.3 Dr Herbst set up a worldwide register of this cancer in young women. He reported in 1979 on the 284 cases he had collected. About two-thirds of these women gave a history of their mother taking DES during pregnancy. The cancer is linked with the drug, but as Herbst has said: “We have clearly stated that the occurrence of these cancers is not due to DES alone.” Also about 900) of the “DES daughters” had adenosis of the vagina and they were more likely to have had miscarriages. There may be an increased incidence of genitourinary abnormalities in male offspring, and it is anybody’s guess what the effects might be as the sons and daughters get older.

The first case against a manufacturer was brought in 1971, and there are now more than 500 lawyers concerned in DES suits. One typical case is that of Joyce Bichler. In 1953 Dorothy Bichler, Joyce’s mother, was given a prescription for DES for vaginal bleeding while pregnant. Nobody knows who made the drug she was prescribed. The doctor prescribed the drug because he had read about it in a medical journal and knew “gynaecologists all over the world” were using it.

Joyce Bichler was born normal and healthy in January 1954, but in 1971 she had cancer diagnosed and underwent hysterectomy and vaginectomy. In October 1974 she and her father brought an action against Eli Lilly and Company, the Bronx Lebanon Hospital Centre, and the doctor. In March 1975 they also sued the chemist who had sold Dorothy Bichler the drug, but this suit was dismissed in May 1978. The case against the hospital was dismissed in April 1977.

In 1979 the court set a date for the remaining trials, ordered that there should be a separate trial on whether Lilly made the drug that Dorothy Bichler took, and also allowed that the plaintiff could maintain her case against Lilly even if she could not prove that the company had made the drug. The doctor settled out of court for $30 000, and the trials started in May 1979. The first jury decided that Lilly did not make the drug. In a second trial the jury found Lilly liable and awarded $500 000 damages. The trial ended on 16 July 1979, and Lilly are now appealing.

The decision is remarkable in several ways. It seems to fly in the face of the law written down in the Restatement (Second) of Torts. Drugs are products which are regarded as “unavoidably unsafe” and a manufacturer is not liable for every injury. The manufacturer is required to give a warning, however, “if he has knowledge, or by the application of reasonable, developed human skill and foresight should have knowledge, of the presence of the ingredient and the danger.” Also, Eli Lilly were held liable even though it could not be proved that it had made the drug because it had acted “in concert with unidentified other drug companies” in the testing and marketing of DES.

In another DES case this year the Supreme Court of California decided that a woman, Judith Sindell, who claims to have been injured by DES (and does not know which company made the drug) can sue all the companies who have manufactured DES. The only precedent in tort law is a case in which a hunter was shot while out with two other hunters. The court then was sure that one of the two hunters was negligent but as it could not know which it found both liable. It does seem a big jump, however, from holding two people liable knowing that one was negligent to holding almost a whole industry liable. Indeed, there is an attempt in the Californian legislature to overturn the Supreme Court’s decision.

Many lawyers see the Californian decision as a legal breakthrough: several women have suffered awful injuries and they should be compensated; the drug companies make money out ofsuccessful drugs, and they should beprepared to compensate for damages; the question of fault is irrelevant-it is simply a case that the drug companies are best able to pay. The drug companies, however, see this as an awful decision. The costs will be enormous, they argue; drug prices will rise steeply; competition and innovation will be reduced; companies will go bankrupt; and also companies will stop producing unpatented drugs. That would mean an end to generic prescribing, something that the Federal government is trying to introduce.

Failure to warn

American case law seems to dictate that a drug manufacturer cannot be liable for a side effect that he has warned a doctor about. Nor could the manufacturer (at least before the DES cases) be liable for not warning about unforeseeable side effects. Variations in State law and individual court decisions have made for inconsistencies, however, as in other product liability cases.

Richardson-Merrell marketed MER/29, a drug for lowering blood cholesterol concentrations, in April 1960 without any warnings of serious side effects. In mid-1961 the company produced a warning about possible hair loss and in December 1961 they added warnings about the possibility of eye damage. The company had, however, known about blindness in rats receiving high dosages since October 1960. The first human cases were reported in October 1961.

Some 5000 people were injured, but only 1500 filed suits, and of the five reported cases the plaintiff won in only two. Mr Toole took the drug from July 1960 until December 1961 and developed cataracts in both eyes. A Californian court in 1969 found for Mr Toole and awarded him $250 000 on the grounds of negligence in failing to adequately test the drug, failure to provide adequate warnings, fraud, and breach of express and implied warranty.

Mr Cudmore in Texas, however, got nothing for the same injuries. The court ruled that the manufacturer had no duty to warn unless “foreseeable” harm would result to “an appreciable number of persons.” Mr Lewis in Oregon also got nothing and the court ruled that: “We held that upon such facts a drug, properly tested, labelled with appropriate warnings, approved by the Food and Drug Administration, and marketed under federal regulation, is as a matter of law, a reasonably safe product.”

This raises another fundamental issue: does a Government licence mean that a drug has by definition been adequately tested ? The drug manufacturers think that they are caught in a double bind: they must spend a great deal of time and money to fulfil the FDA licensing criteria but in most States this gives them no legal protection if a serious side effect is subsequently discovered.

Claims against prescribing doctors

In the United States injured people who are seeking compensation will commonly sue everybody possible. If they think that they have a good case against a drug company they will concentrate their energies there. Doctors are not involved when there is a defect in the drug or in the manufacturer’s warnings.

But claims are upheld against doctors in an inconsistent way for the following reasons: failing to follow the manufacturer’s labelling; ignoring contraindications; ignoring warnings against method of use; ignoring recommended dosage; using the wrong drug; and failing to obtain informed consent.

Some of these forms of liability will not seem outrageous to British doctors, but I want to dwell a little on following the manufacturer’s instructions and informed consent. Some British doctors are worried that if new product liability legislation is introduced they will have to follow manufacturers’ instructions strictly to avoid litigation. But this is not the case in the litigious United States. The AMA has said: “Drug labelling may have evidentiary weight for or against a physician, but the evidence is subject to refutation; drug labelling, per se, does not set the standard for what is good medical practice.” Another worry of some British doctors is that they will be obliged to tell patients of every conceivable side effect to avoid litigation. Again, this is not the case in the United States. The Americans do have a law of informed consent, but as George J Annas has written in the New England Journal of Medicine:

Perhaps the legal profession has been derelict in its exposition of the doctrine of informed consent, but it strikes me as almost incomprehensible that any physician would believe he had to “persist with a potentially frightening dissertation for ‘legal reasons“‘ in the face of a patient who protests that he does not want to hear it. This situation, of course, would be easily understood without reference to legal authority by anyone who understood the primary purposes of the informed-consent doctrine; to protect the patient’s right of self-determination, and to promote rational decision making. The first means that a patient’s expressed desire not to be told about risks should be honoured and the second that if the physician can document that risk disclosure will make the patient too ill or emotionally distraught as to foreclose a rational decision, no such disclosure need be made.

Even in the United States a doctor is not legally required to tell his patient everything.

Richard Smith, 1981

Click to download the full study.

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The DES Cases and the Problem of Proving Causation

In January and February of 1976, army personnel at Fort Dix, New Jersey, became ill with flu-like symptoms. When studies showed a viral infection similar to the one responsible for the 1918-1919 Swine Flu pandemic, President Ford (and others) urged the appropriation of emergency funds for a nationwide influenza immunization program. Congress hurriedly appropriated $135,064,000, but problems developed almost immediately. One of the four manufacturers of the vaccine produced the wrong strain, and distribution was delayed. All four manufacturers raised liability insurance concerns and were unwilling to provide any vaccine without adequate insurance coverage. Concern arose that the mass-immunization program would not begin before the influenza season.

Mass immunization under The Swine Flu Act

The Congressional Response

Liability in Mass Immunization Programs, BYU Law Review, Volume 1980 | Issue 1 Article 6, s, 1980 BYU L. Rev. 69 (1980).

President Ford’s active involvement as well as the publicity associated with the mysterious outbreak of Legionnaires Disease in Philadelphia in July 1976, may have provided the needed stimulus for congressional action. The Swine Flu Act-provided the necessary assurance to the drug manufacturers by making lawsuits against the government the exclusive remedy for all actions connected with the Swine Flu program. The Act was passed precipitously, but not without concern that it could create an undesirable precedent. The United States accepted liability “for personal injury or death arising out of the administration of swine flu vaccine under the swine flu program and based upon the act or omission of a program participant in the same manner and to the same extent as the United States would be liable in any other action brought against it under the Federal Tort Claims Act.

Although the government cannot be held strictly liable under the Federal Tort Claims Act: the flu statute contained an exception: the liability of the United States could “be based on any theory of liability that would govern an action against such program participant under the law of the place where the act or omission occurred, including negligence, strict liability in tort, and breach of warranty. “Program participant” was to mean the manufacturer or distributor of the vaccine, and the public or private agencies, organizations, and medical personnel who provided swine flu inoculations without charge and in compliance with the informed consent form and procedures. The government also agreed not to invoke the “discretionary” act exemption of the Federal Tort Claims Act. Furthermore, if the swine flu action was brought within two years of the date of inoculation and was dismissed for failure to file an administrative claim, a plaintiff was given the longer of thirty days after dismissal or two years from the date the claim arose to file an administrative claim. The remedy against the United States was exclusive, and the case was to be tried without a jury as under the Federal Tort Claims Ac. Notwithstanding any provision of state law, the United States was entitled to indemnity against any program participant whose failure to carry out a contract with the government or whose negligence caused the injury.

A key concern addressed in the Act was the development of “a written informed consent form” with accompanying procedures, to assure that the risks and benefits from the swine flu vaccine were fully explained to each individual to whom the vaccine was to be administered. The Secretary of Health, Education, and Welfare (HEW), in consultation with the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, was directed to draft and implement this form.18 Notably, the consent form that was developed did not specifically warn of the possibility of contracting Guillain-Barre disease, a neurological disorder. After describing the influenza and the vaccine, the form included a paragraph entitled “Special Precautions,” which stated: “as with any vaccine or drug, the possibility of a severe or potentially fatal reaction exists. However, the flu vaccine has rarely been associated with severe or fatal reactions.” The vaccinee, or his guardian, signed in two places to affirm that he had read the statement about swine flu and the special precaution. A second form indicating that legal remedies were available against the United States Government was also distributed.

The Act required the Attorney General to defend all claims arising out of the swine flu program against federal government employees or program participants and their insurers. Upon certification of the Attorney General, the United States was to be substituted as party defendant and the action removed to the appropriate federal district court. However, a program participant could lose its protected status if it failed to cooperate with the government in processing or defending a claim. If this occurred, the court was required to substitute that party as defendant in place of the United States, and upon motion, remand any such suit to the court in which it was instituted. Of course, status as a program participant required that the public or private agency or health personnel provide the inoculation without charge and in compliance with the informed consent procedures.

The Guillain-Barre Litigation

Public concern about the safety of the vaccine and skepticism of the need for the program plagued the mass immunization efforts. After reports of suspected association between the swine flu vaccine and Guillain-Barre syndrome, the program was halted in December 1976. Under the provisions of the Federal Tort Claims Act, as incorporated in the Swine Flu Act, a claim had to be filed within two years after accrual.26 For nearly all claimants the accrual date would be the date of inoculation or shortly thereafter; hence, the filing deadline for most claimants would have been within a short period after December 1978.

As of December 1979 a total of 912 suits had been filed against the United States for $1,150,000,000 in damages. Of these suits, 814 have been consolidated for pretrial procedure in the District of Colombia. Four hundred and ninety-four of the claimants allege Guillain-Barre syndrome, 121 allege other neurological disorders, and 252 claim non neurological disorders. Forty-five deaths are alleged to have occurred as a result of Guillain-Barre. As of December 1, 1979, 3,813 administrative claims had been filed for a total of $3,417,000,000 in damages. Of these claims, 118 have been paid (settlements totaled $3.7 million), 1,580 have been denied, and 102 have been closed (withdrawn or abandoned by the claimant).

On June 16, 1978, HEW Secretary Califano announced that claimants for federal compensation would not need to prove negligence by Federal workers or others in the Swine Flu program as required by Federal law and the law in many state. Most claimants could therefore recover by showing that they developed Guillain-Barre as a result of the vaccination and that they consequently suffered the alleged damages. The Secretary adopted the policy for two related reasons. The first was that the consent form had neither warned individuals that there was a “one in one hundred thousand” risk that a person would contract Guillain-Barre, nor that “one in every two million” would die from the condition. The second was that the federal government, in an unprecedented effort, had actively urged Americans to be vaccinated. The Secretary emphasized, however, that this policy did not apply to any non-Guillain-Barre cases arising under the swine flu program, or to claims arising under any other government sponsored or supported immunization program.

Scope of Government and Manufacturer Liability

To date, constitutional attacks on the Swine Flu Act have been made in four reported cases. The statute has been attacked as being violative of due process, equal protection of the laws, the seventh amendment right to trial by jury, and the tenth amendment reservation of power to the states. Nevertheless, the constitutionality of the Act has been upheld in all the cases.

Before enactment of the federal liability legislation, some states, led by California, had adopted legislation exempting participants (licensed health professionals or facilities) from liability unless their behavior involved willful misconduct. In a recent swine flu case, the California statute was upheld despite claims that it involved special legislation, fostered economic discrimination, and violated the supremacy clause.36 When the federal legislation assumed its present form, the federal government was to be liable only if a private person “would be liable to the claimant in accordance with the law of the place where the act or omission occurred.” Therefore, in states like California, those injured by negligence during the administration of the program may receive no compensation.

Claims brought directly against the vaccine’s manufacturers have been similarly unavailing. An argument made in such efforts to sue the manufacturers directly is that the signing of an informed consent form is a sine qua non of the Act’s operation. This, however, is troublesome in view of the fact that an estimated 13% of those vaccinated may never have signed any form. In a recent case, the plaintiff, a doctor who had inoculated herself without signing the form, argued that because she had not signed the form her case fell outside the scope of the Act. The court refused to hold that drug manufacturers were required to comply with the informed consent procedures before they could be considered program participants. In dictum, however, the court stated that it was “arguable” that program participant status might not be conferred on an inoculating agency or other health personnel absent such compliance.

The full range of injuries to be compensated under the provisions of the Act remains undetermined. The language used by Congress is very broad, referring as it does to personal injury or death arising out of the administration of swine flu vaccine under the swine flu program and based upon the act or omission of a program participant. The Act further provides that “liability” may be based on any theory that would govern an action against such program participant under the law of the place where the act or omission occurred, including negligence, strict liability in tort, and breach of warranty. Injuries resulting from negligently broken or unsterilized injectors, or from negligently administered inoculations, would certainly be covered in those jurisdictions where negligence is actionable, but other situations are less certain. For example, a pending case alleges that the plaintiff fainted while leaving the building in which she had received a swine flu vaccination. Her fall resulted in several chipped teeth. If she merely tripped over a step, or had fallen on her way into the building, her injury could arguably fit within the broad language of the Act. Another injury arguably within the scope of the Act is negligently inflicted emotional distress. Many jurisdictions recognize the tort, especially where the requisite “impact” has been alleged. The inoculation itself would surely be sufficient impact.

Liability of Drug Manufacturers

During the Senate debate on the proposed swine flu legislation, many were made uneasy by the fact that the insurance companies viewed the risks of the program as being too great to insure against. A brief review of recent cases involving the liability of drug manufacturers in regard to ethical drugs suggests that the concern was not unfounded.

Drug Liability and the Duty to Warn

A claimant in any product liability action usually has a choice of several legal theories. Depending on the law of the jurisdiction and on the facts of the case, a plaintiff may proceed on theories of negligence, breach of warranty (implied or express), strict liability in tort, or misrepresentation. Obviously, practical considerations regarding evidentiary matters, the relevant statute of limitations, available defenses, and the availability of punitive damages, may well make one theory preferable to another. But often, the pleadings are couched in the alternative. The claimant with a drug related injury is no different from other plaintiffs in that he must allege one of the above legal theories in order to be heard and must establish the elements of his case in order to prevail. To date, the concept of no-fault recovery for drug-induced injuries urged by several legal scholars, particularly in mass immunization cases:= has been resisted in this country. The courts have also been unwilling to hold manufacturers “absolutely liable,” rejecting the theory that the production of drugs is an ultrahazardous activity.

The ethical-drug manufacturer has a duty to test and develop the drug properly,47 to comply with all government regulation : to keep abreast of developments in regard to the drug and to warn of side effects-a troublesome responsibility in recent years.

In the case of prescription drugs, a warning to the doctor is ordinarily held to satisfy the manufacturer’s duty. For a breach of that duty, the manufacturer is directly liable to the patient. It has been said that the manufacturer’s compliance with this duty enables the prescribing physician, the learned intermediary between the purchaser and the manufacturer, to balance the risk of possible harm against the benefits to be gained by the patient’s use of the drug. The rationale is that if the doctor is properly warned there is an excellent chance that injury to the patient can be avoided. This is particularly true if the injury takes place slowly. The duty to warn the medical profession is not measured in all cases by quantitative standards. In some circumstances, the manufacturer may have a duty to warn those few persons it knows will be injured by the drug’s side effect. Furthermore, the warning has to be brought home to the doctor undiluted by overpromotion of the drug.

A further controversial and unresolved question is whether a drug manufacturer may be held liable for failure to warn of unforeseeable risks, or whether its liability for failure to warn is limited to those risks which it knows or has reason to know are inherent in the use of its drug. In a recent case, Hamilton u. Hardy, the two theories were distinguished by the Colorado Court of Appeals. Finding error in the trial court’s refusal to instruct the jury on strict liability for the defendant doctor’s failure to warn concerning the dangers of Ovulen, the court remarked that the evidence which proves a failure to warn is the same under both theories, but refused to find the theories identical.

Under strict liability, the test is whether the failure of Searle to adequately warn of the potentially dangerous propensities of its product rendered that product unreasonably dangerous. It is of no import whether the drug manufacturer’s warning comported with the warning a reasonably prudeht drug manufacturer would have given. Strict tort liability shifts the focus from the conduct of the manufacturer to the nature of the product.

The court proposed the following test to determine whether the evidence submitted warranted a finding for the plaintiff:

A way to determine the dangerousness of the article, as distinguished from the seller’s culpability, is to assume the seller knew of the product’s propensity to injure as it did, and then to ask whether, with such knowledge, he would have been [acting unreasonably] in selling it without a warning.

The opposing view was articulated clearly by the Michigan Supreme Court in the recent case of Smith v. E. R. Squibb & Sons, Inc. The plaintiffs deceased wife suffered a rare anaphylactic reaction when the defendant’s product, Renografin-60, was injected into her blood stream. Breach of implied warranty and negligence were pleaded, but the trial court refused to instruct the jury regarding the warranty theory. The supreme court affirmed, commenting:

When the factual issue is not whether the product itself is defective, but is whether the manufacturer has provided adequate warnings, the existence of a product defect and a breach of duty is determined by the same standard-reasonable care under the circumstances… …  Consequently, when liability turns on the adequacy of a warning, the issue is one of reasonable care, regardless of whether the theory pled is negligence, implied warranty or strict liability in tort.

It has been held that the manufacturer’s duty to warn the medical profession extends beyond the prescribing physician. In a case involving oral contraceptives, the Oregon Supreme Court stated:

It is especially important that the treating doctor receive the manufacturer’s warning where it is impossible to predict in advance whether a particular patient is apt to suffer adverse effects from a drug, since the treating doctor may be more likely to observe the actual symptoms of the drug’s untoward consequences… … The warning should be sufficient to apprise the general practitioner as well as the “unusually sophisticated medical man of the dangerous propensities of the drug.

The Polio Cases and the Duty to Warn

Several recent cases involving polio vaccines have further delineated the drug manufacturer’s duty to warn, and in so doing have greatly alarmed the drug industry. The original polio vaccine was the Salk vaccine (dead virus). Later the Sabin oral vaccine was developed, as types I, II, and III. The Sabin vaccine was licensed by the Division of Biologic Standards (DBS), which was then a part of HEW. In 1960 an advisory committee was established by the Surgeon General to review polio prevention. After a showing of some association between the type I11 Sabin polio vaccine and the development of polio in adults, the advisory committee recommended in 1962 that the vaccine’s use be limited to children in nonepidemic situations. The committee further recommended that the type I11 vaccine only be used for adults with the full recognition of its minuscule risk (estimated to be about 7.6 per million for persons over twenty years of age). The manufacturers sold their vaccines to mass immunization clinics that were often established with the assistance of drug salesmen. In most instances, no warnings were given, and doctors did not individually evaluate a person’s need for the drug.

In Davis v. Wyeth Laboratories, Inc, the plaintiff contracted polio thirty days after receiving a type III Sabin vaccine in a Montana clinic. A pharmacist had been delegated the task of administering the vaccine in the absence of a doctor. The court considered the manufacturer’s alleged failure to warn the plaintiff of the risk as sufficient to expose it to strict liability in tort. Since the vaccine presented a known risk that could not be narrowly defined, it could be properly marketed only by full disclosure of the existence and extent of the risk involved. The court observed that the risk of the plaintiff contracting polio from the wild virus was about the same as the risk of contracting polio from the vaccine. Even though Wyeth had technically warned the medical society, it failed in its responsibility since it knew that the drug was not dispensed as a “prescription drug” and that the warnings were not reaching the consumer. The court suggested means of communication the manufacturer could have undertaken, such as advertisements, posters, oral warnings, or releases to be read and signed by recipients of the vaccine.

In Reyes u. Wyeth Laboratorie , an eight month-old child given trivalent vaccine at a health clinic in a rural Texas community developed polio. The mother had been given no warnings by the registered nurse who administered the vaccine. Although the defendant contended that there was an epidemic of wild polio in the county at the time the child became ill, and that Samples of the virus taken from the child upon admission to the hospital were “probably wild, 70 the jury found that the vaccine caused the child’s polio. The court established two tests whereby a manufacturer would be liable: (1) whether the product was so unsafe that its marketing alone was “unreasonably dangerous per se,” or (2) whether the product was marketed without sufficient safeguards and was therefore “unreasonably dangerous as marketed. Because of the legitimate public interest in preventing polio, marketing the vaccine was held to be justified. However, under the circumstances of the vaccine’s administration, where no individualized medical judgment intervened between the manufacturer and the ultimate consumer, the manufacturer was “required to warn the ultimate consumer, or to see that he was warned. The court postulated a rebuttable presumption that the consumer would have read any warning provided by the manufacturer, and acted so as to minimize the risks.

The fifteen year old patient in Cunningham v. Charles Pfizer & Co. was given the type I Sabin vaccine in a Tulsa, Oklahoma clinic and subsequently developed polio. The defendant claimed there was no evidence that the plaintiff would have refused to take the vaccine had the warnings been given to him or to his parents. The court held that the plaintiff was not required to present any direct evidence on this point and was entitled to a rebuttable presumption. In view of the fact that there was considerable risk of contracting polio from natural sources at the time the vaccine was given (twelve cases of polio occurred in Tulsa during October and November 1962, two months before the plaintiffs inoculation), the court concluded that the issue of whether the plaintiff as a reasonably prudent person would have refused to take the vaccine had adequate warning been given was for the jury.

In Givens v. Lederle, the plaintiffs young daughter was given an oral vaccine by her pediatrician. The mother, who had never received a polio vaccination of any kind, developed polio within nine days of her daughter’s ingestion of the third dose of vaccine. On the insert packaged with the vaccine, the defendant Lederle had stated that:

Para1ytic disease … has been reported … in some instances, in persons who were in close contact with subjects who had been given live oral polio virus vaccine. Fortunately, such occurrences are rare, and it could not be definitely established that any such case was due to the vaccine strain and was not coincidental with infection due to naturally occurring poliomyelitis, or other entroviruses.

Mrs. Givens had received no warnings from her pediatrician. At the first trial, the judge had kept the jury from hearing evidence on the issue of whether oral vaccine can cause polio. After the Reyes decision, the court reversed itself and granted the plaintiffs motion for a new trial. In turn relying upon Reyes, the reviewing court upheld the lower court’s action, and stated that in Reyes it was not a significant factual distinction that the vaccine had actually been ingested by the plaintiff, because the defendant’s “warning” admitted that some persons in close contact with vaccinees had developed paralytic diseases. The only issue was whether polio could be transmitted to someone in close contact. Testimony showed that a mother changing her baby’s diapers would be particularly susceptible to contracting the disease. In addition, because administration of the vaccine by a private pediatrician rather than personnel in a county health clinic, was not “nearly so great” a difference as the defendant had argued it to be, the manufacturer’s duty to warn the patient extended to this situation. The doctor testified that the vaccine had been administered in a manner more similar to procedures followed at a small health clinic than to normal procedures used in prescribing drugs. If this was true, then the defendant was responsible for taking definite steps to warn the consumer directly. Even if the drug were considered a prescription drug, the court found that the enclosed warning did not adequately state the risk. The doctor testified that the manner of stating the one in three million risk was a “very nebulous way of putting it.

Thus, the drug manufacturers duty to warn has been extended beyond the prescribing physician to the entire medical community. How this warning is to be communicated to doctors specializing in different areas of medicine is not clear. Furthermore, in the absence of a learned intermediary, the warning must be given to the patient himself, and sometimes even to a third party. In Givens a close relative was allegedly harmed, but the court did not limit its holding to close relatives. Therefore, the scope of the duty owed third persons remains unclear. It is also unclear how a proper warning is to be drafted when a manufacturer possesses incomplete information, but has some suspicion, based on a statistically small sample of reported cases, that its drug may cause adverse side effects.

The fact that the drug package insert has been approved by the FDA does not relieve the drug manufacturer of its obligation to communicate an adequate warning to the users of the drug. An Oregon case indicating that a drug complying with FDA regulations was reasonably safe as a matter of law has been expressly overruled. The warnings required by such agencies may be only minimal,sl and therefore do not provide an adequate standard by which to measure a manufacturer’s duty.

The DES Cases and the Problem of Proving Causation

There are other uncertainties peculiar to drug litigation. Because of the lengthy time interval between ingestion of a drug and manifestation of the injury, and the even longer period between the injury and the identification of the drug as its probable cause, a plaintiff may have difficulty in identifying the drug’s manufacturer. Nowhere is this problem evidenced more clearly than in the current DES litigation.

In 1941 the FDA approved DES after twelve drug companies filed new drug applications. In support of their request the companies submitted a joint clinical file. The purpose for which the drug was approved in 1941 did not include its subsequent and popular use for the prevention of miscarriages. In 1947 new applications for that use were submitted by the twelve companies and others, and from 1947 to 1971 the drug was manufactured by hundreds of drug companies and prescribed for millions of women. In 1971 statistical evidence indicated a significant association between DES and the development of cancer in the users’ daughters who had been exposed in utero. The FDA banned the drug in 1971 as unsafe and ineffective in preventing miscarriage. Although there were several hundred manufacturers of DES and related drugs, it was estimated that Eli Lilly and five or six other manufacturers accounted for 90% of the market. Nevevertheless, it was extremely unlikely that any plaintiff would be able to trace back the particular DES taken by her mother to any one individual manufacturer.

Prior tort cases provided some guidelines for the DES plaintiffs. Hall v. E. I. Du Pont De Nemours & CO. consolidated two cases arising out of eighteen separate accidents in which children were injured by dynamite blasting caps. The explosions destroyed the evidence of manufacture in most cases. The plaintiffs joined the six major domestic manufacturers of blasting caps and their trade association, alleging that the defendants knew that the caps were dangerous and that they had agreed not to put warnings on them. The court held that the defendants were not entitled to a dismissal of the plaintiffs’ claims since the plaintiffs were claiming joint control of risk by explicit agreement-i.e., concert of action. The court went on to add that the plaintiffs could either submit evidence of defendants parallel behavior sufficient to support an inference of tacit agreement, or allege that, acting independently, the defendants had adhered to an industry-wide standard with regard to the safety of blasting caps. The court discussed enterprise liability and emphasized its special applicability to industries composed of a small number of units. The burden of proving causation was shifted to the defendant despite the possibility that the caps might have come from other unnamed sources.

Another approach for DES plaintiffs is the “alternative liability theory.” In Summers v. Tice, the plaintiffs two companions fired their guns simultaneously and carelessly in his direction. Only one bullet actually hit the plaintiff, but it was impossible to prove which defendant had caused the injury. The court justified its concept of joint and several liability on the grounds that when all the defendants are potential wrongdoers, fairness requires a finding of joint liability unless the defendants can individually exonerate themselves.

In the related case of Anderson v. Somberg, the plaintiff was injured when part of a surgical instrument broke off in his spinal canal during an operation. He sued the doctor and hospital for negligence, the distributor for breach of warranty, and the instrument’s manufacturer in strict liability. The court held that because it was apparent that at least one of the defendants was liable for the plaintiffs injury, all were jointly liable unless proven otherwise. No other theory of liability could reasonably be applied. “Since defendants had engaged in conduct which activated legal obligations by each of them to plaintiff, … the failure of any defendant to prove his nonculpability would trigger liability; and further, … at least one would be liable.

Plaintiffs have recently used analogous arguments-with varying degrees of success-jn attempting to trace liability back to the DES manufacturers. In McCreery v. Eli Lilly & CO. the court refused to accept the “sketchy and limited factual circumstances presented in the plaintiffs argument of concerted activity,” and held that the plaintiff must, “before benefiting from the shift of the evidentiary burden, identify the manufacturer.” Since knowledge of the manufacturer was more accessible to the plaintiff (whose mother had known of and possessed the prescription, and had chosen the doctor and druggist), the court affirmed the summary judgment for the defendant. A contrary result was reached in Sindell v. Abbott Laboratories, where the plaintiffs alleged concerted action and theories of alternative liability. And in the much publicized New York case of Bichler v. Eli Lilly & Co., a jury awarded $500,000 to a twenty five year old woman who developed vaginal and cervical cancer as a result of her mother’s ingestion of DES. There the plaintiff alleged joint enterprise liability. This approach, if successful on appeal, is sure to have a major impact on the more than 400 DES suits still pending.

Application of Statutes of Limitation

Since a plaintiff in a drug liability action may plead a variety of legal theories-e.g., negligence, warranty, strict liability in tort, it is necessary at the outset to determine which statute of limitations period applies to each cause of action pleaded. Typically, the tort or personal injury limitation is two or three years and accrues at the time of injury. The warranty limitation under the Uniform Commercial Code is four years and accrues from the date the sales contract is breached. It is, of course, entirely possible that the limitation period for one cause of action will have expired while that of another remains viable.

A second and far more complicated question is when the cause of action accrues. The Uniform Commercial Code provides that the action accrues when the breach occurs, regardless of the aggrieved party’s lack of knowledge of the breach. A breach of warranty occurs when tender of delivery is made…  Nonetheless, there are at least four points at which a tort cause of action may accrue: (1) when the defendant breaches his duty, (2) when the plaintiff suffers harm, (3) when the plaintiff is or should be aware of his injury, or (4) when the plaintiff is or should be aware of the causal relationship between his harm and the defendant’s misconduct. In most tort actions these events occur simultaneously and the time of accrual is clear. But this is seldom the case in drug induced injuries. It is impossible to generalize the law regarding statutory interpretation insofar as it affects drug litigation, except to point out that it is in a state of flux.

Some jurisdictions, led by New York, have adopted the strict position that the cause of action accrues when there is a wrongful invasion of personal or property rights, regardless of whether the plaintiff realizes he has been injured. Most lower courts in New York have persisted in this “first breath” rule, despite a more liberal approach to malpractice claims that involve the leaving of a foreign object in a patient’s body-for which the statute does not begin to run until the patient could reasonably have discovered the injury106-and despite the more liberal tolling of the statute by the continued treatment by the physician. Recently, exceptions to these rules have been made in products liability cases brought for occupational disease in strict tort liability. It has also been held that the continuous treatment of an attending physician may be imputed to the manufacturer of a medical device, thus tolling the statutory period applicable to claims against the manufaturer.

Other jurisdictions have adopted the liberal discovery of injury rule. Yet even with these jurisdictions generalizations are dangerous. Clearly, the plaintiff may learn of his injury many years before he is able to identify its cause. Some courts have held that the statute begins to run at the time the plaintiff knew or should have known of his injury. Knowledge of injury is only apparent if the injury is a “traumatic” one. However, if the plaintiff has not been made aware that his rights were violated, the modern trend and majority position in products liability actions is that the plaintiffs action accrues when he discovers, or in the exercise of reasonable diligence should discover, that his injury may have been caused by the defendant’s conduct, rather than when he simply discovers that he has been injured. On the issue of fairness to the drug companies, the New Hampshire Supreme Court has observed:

With respect to their expectations of repose, drug companies are unique among most potential tort feasors. The harmful propensities of drugs are often not fully known at the time the drugs are marketed. These companies know or at least should expect that some time may pass before the harmful effects of their products manifest themselves in drug users and that there may be another lapse of time before the injured person is able to discover the causal connection between his injury and the drug he consumed…. Given these unique circumstances and the fact that the scope of a drug manufacturer’s liability is substantial and seems to expand continually through the growth of substantive tort and warranty doctrines, … we do not think the drug company can reasonably expect to be immune to suit before its customer has a fair opportunity to discover the company’s tortious conduct.

The Recent DES Case of Mink v. University of Chicago

A recent case, Mink v. University of Chicago,l13 posed many of the issues discussed in this article. There the plaintiffs brought a diversity action on behalf of themselves and some 1,000 women who were given DES as part of an experimental study allegedly conducted by the named defendant and Eli Lilly & Co. They claimed that they and their children had suffered reproductive tract abnormalities and had incurred an increased risk of cancer. In their complaint they sought recovery on three causes of action. They first alleged battery, since the medical experiment was conducted without their knowledge or consent. The court distinguished this case from those in which the patients at least knew that they were being given some form of a drug. In those cases negligent failure to disclose risks had to be pleaded and proved, and injury had to be alleged. The gist of the battery claim was nonconsent-the tort being complete without hostile intent, and without personal injury. The issue of whether implied consent had been given was left to the jury. The second count was in strict liability and was dismissed because the named plaintiffs had alleged no injury to themselves. In their amended complaint they sought damages for alleged injury to other class members, but this was held to be an insufficient allegation of injury to the named plaintiffs. The third claim was that no effort had been made to notify the plaintiffs of their participation in the experiment until 1975 or 1976, even though the relationship between DES and cancer was known to the medical community as early as 1971. The court recognized a continuing duty to warn on the part of both the university and the drug manufacturer, but dismissed this count for failure to state a cause of action. In their amended complaint, plaintiffs sought to compel the defendants to notify all the women given DES as part of the experiment. Since the plaintiffs proposed class had never been certified, and since the named plaintiffs already were aware of the DES menace, the plaintiffs could not show that there was an ongoing controversy at the time the complaint was filed. The named plaintiffs knew of the dangers and thus had no need for further notice.

The concerns of the manufacturers and their insurers therefore appear more understandable in the context of recent developments in drug litigation. Despite the articulated concerns of Congress, it seems inevitable that future mass inoculation programs will involve an attempt to have the government underwrite the costs of liability. For this reason it is important to refer to the Federal Torts Claims Ad, and particularly to the “discretionary act” exception, which has so often been invoked by the government in avoiding liability.

Mass Immunization and The Federal Tort Claims Act

Two cases are particularly relevant in considering governmental liability for drug approval and distribution. In Griffin v. United States, the plaintiff allegedly contracted polio as a result of ingesting the type III Sabin vaccine. She brought an action against the government claiming that the vaccine had been negligently tested by the Division of Biologic Standards (DBS) and had been approved for release in violation of agency standards. Since the application and not the content of the agency rules was attacked, the court held that the discretionary function exception did not apply. The court commented:

The “discretion” protected by the section is not that of the judge-a power to decide within the limits of positive rules of law subject to judicial review. It is the discretion of the executive or the administrator to act according to one’s judgment of the best course, a concept of substantial historical ancestry in American law… Where there is room for policy judgment and decision, there is discretion.

While DBS had the right to weigh five criteria of neurovirulence , its judgment was that of a professional, not a policy maker. It was purely a scientific determination since DBS’ responsibility was limited to merely executing the policy judgments of the Surgeon General. Furthermore, in approving this lot of vaccine, DBS had exceeded its authority by disregarding the mandatory regulatory command and had diluted the results of the tests performed by considering “biological variation.” The violation of a nondiscretionary command takes what otherwise might be characterized as a ‘discretionary function‘ outside the scope of the statutory exception.

However, in Gray v. United States the plaintiff was unsuccessful in her suit. She alleged that she had been injured when her mother ingested DES and sued both Eli Lilly and the federal government, relying on Griffin as precedent. Summary judgment was granted both defendants. The court commented that the FDA was given a general statutory mandate to assure the public that a marketed drug was safe for use. There were no particular scientific tests or measuring sticks existing whereby the FDA had to qualify a new drug, but rather it was given the liberty to consider all factors it deemed relevant in the determination of a drug’s safety. Congress had chosen the FDA to be the decision maker, … and its judgments … must be beyond private scrutiny and litigation.

Conclusion

Thus, a clear message emerges: in any future mass inoculation program, agency action must be “nondiscretionary” if the federal government is to be held liable. To the extent possible, specific “measuring sticks” or tests should be specified. In view of the strict liability claim frequently made in drug litigation, it is likely that the government will be forced to concede liability on that ground despite the present limitation on liability. It is clear that the government must develop clear guidelines for protecting participants in the mass immunization programs it deems necessary. In the absence of such protection, we may expect continued resistance from drug manufacturers, health care providers, and their insurers to any participation in such programs.

Nina S. Appel, 1980

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